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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL153570-01A1 | U.S. NIH Grant/Contract | View source | |
| A536771 | Other Identifier | UW Madison | |
| Protocol Version 2/24/2023 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will pilot test a just-in-time (JIT) adaptive intervention to reduce severe respiratory illness, for children with severe cerebral palsy (CP). The intervention program, called RE-PACT, delivers timely, customized action planning and health coaching when mobile text messaging with families predicts hospitalization risk is elevated. A total of n=90 caregivers of children with severe CP will be enrolled from the University of Wisconsin-Madison (UW) and the University of California, Los Angeles (UCLA) and can expect to be on study for up to 6 months.
The two-site study takes place at clinical programs at US children's hospitals: the UW and UCLA Pediatric Complex Care Pro-grams were each established to deliver care to children with medical complexity. Each program is comprised of primary care providers, care coordinators, and extended visit lengths, deliver comprehensive care to children with cerebral palsy. These sites have existing collaborative relationships through their participation in the CYSHCNet national research network (http://cyshcnet.org) and other federally funded initiatives, and a track record of successful productive scientific collaboration.
The study period will be divided into three waves: after each wave, feasibility, acceptability, and fidelity data will be reviewed against pre-defined measures of success to adjust the protocol and overcome implementation barriers.
This study will be conducted through a six-month randomized pilot trial. Briefly, after recruitment and baseline assessments, eligible caregiver/child dyads are randomized to intervention (I) or active control (AC). Intervention subjects receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. AC subjects will receive usual comprehensive medical care and coordination. Assessments of feasibility, acceptability and fidelity, as well as clinical outcomes, will be conducted at baseline and monthly intervals for 6 months. Intervention outcomes will be evaluated at baseline (i.e., randomization) and 6 months post-enrollment, and will also include the primary clinical outcome (i.e., hospitalization for respiratory diagnosis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RE-PACT Intervention | Experimental | Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. |
|
| Active Control (AC) | No Intervention | AC subjects will receive usual comprehensive medical care and coordination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RE-PACT Intervention | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Number of Days to Meet Target Enrollment Size | Feasibility will, in part, be measured by the number of days to meet target enrollment by wave. There are a total of 3 recruitment waves. This Outcome Measure was assessed by child. | up to 3 months |
| Feasibility: Median Number of Days Between Randomization and Intervention Activities | Feasibility will, in part, be measured by the number of days between randomization and (time zero) intervention activities. This Outcome Measure was assessed by child. | up to 3 months |
| Feasibility: Mean Number of Minutes Logged for Action Planning | Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child. | up to 6 months |
| Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching | Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child. | up to 6 months |
| Feasibility: Mean Number of Intervention Triggers Per Patient | Feasibility will, in part, be measured by the number of intervention triggers per patient (annualized), including respiratory and non-respiratory triggers. This Outcome Measure was assessed by child. | up to 6 months |
| Feasibility: Incidence of Data Infrastructure Issues | Feasibility will in part be measured by the presence of necessary data infrastructure issues. This is a measure of the presence of complete data collection, between 2 sites, data use agreements and Institutional Review Board reliance. This outcome includes any events that occur over the study duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Respiratory Diagnosis Requiring Hospitalization | Severe respiratory illness, defined as respiratory diagnoses requiring hospitalization. Respiratory diagnoses includes discharge diagnosis of any of the following: asthma, pneumonia (community or hospital acquired), bronchiolitis, influenza, upper or lower respiratory tract infection, tracheitis, aspiration pneumonia/pneumonitis, chronic lung disease, respiratory failure. - Number of children with at least 1 severe respiratory illness |
| Measure | Description | Time Frame |
|---|---|---|
| Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score | Capability is in part measured by the FCAT mean composite score,. FCAT is a 10-item survey to assess the caregiver's challenges on the day it is taken, scored on a 5 point likert scale from 1 (disagree strongly) to 5 (agree strongly). The mean composite score ranges from 1 - 5 with higher scores indicating higher activation. Activation of a family member refers to their desire, knowledge, confidence, and skills that can inform engagement in healthcare. |
Inclusion Criteria:
Be at least 18 years of age
Primary caregiver to an eligible child (child criteria below)
Speak English or Spanish well enough to be interviewed
Have a phone capable of sending/receiving text messages
Has a child
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Coller, MD, MPH | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Los Angeles | California | 90095 | United States | ||
| University of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40522978 | Derived | Coller RJ, Singh-Verdeflor K, Eickhoff J, Chung PJ, Kloster HM, Cushing CC, Gerber DM, Katz BJ, Ia S, Wagner T, Delgado-Martinez R, Warner G, Porras-Javier L, Klitzner TS, Lerner CF. Preventing respiratory illness in cerebral palsy: Results of a pilot randomized controlled trial. PLoS One. 2025 Jun 16;20(6):e0325970. doi: 10.1371/journal.pone.0325970. eCollection 2025. | |
| 38190242 | Derived | Fleischman A, Lerner C, Kloster H, Chung P, Klitzner T, Cushing C, Gerber D, Katz B, Warner G, Singh-Verdeflor KD, Delgado-Martinez R, Porras-Javier L, Ia S, Wagner T, Ehlenbach M, Coller R. Adaptive Intervention to Prevent Respiratory Illness in Cerebral Palsy: Protocol for a Feasibility Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 8;13:e49705. doi: 10.2196/49705. |
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The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Data prepared for distribution under a data-use agreement will be redacted to ensure privacy of study participant identity. The data-use agreement will include requirements to protect participants' privacy and data confidentiality. It will prohibit the recipient from transferring the data to other users and require that the data's security be protected by standard means and be used for research purposes only.
Data from this study may be requested from other researchers after the completion of the primary endpoint analyses by contacting the study PI.
The method of distribution will be by request to the study PI. After review and approval, a requestor completes the data-sharing agreement, requestor will receive a limited dataset mailed by CD or emailed through UW-Madison secured email systems that require users to create an account and sign-in with a username and password in order to receive and download any type of sensitive data.
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| ID | Title | Description |
|---|---|---|
| FG000 | RE-PACT Intervention: Child | Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. RE-PACT Intervention:
|
| FG001 | RE-PACT Intervention: Caregiver | Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. RE-PACT Intervention:
|
| FG002 | Active Control (AC): Child | AC subjects will receive usual comprehensive medical care and coordination. |
| FG003 | Active Control (AC): Caregiver | AC subjects will receive usual comprehensive medical care and coordination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | RE-PACT Intervention: Child | Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. RE-PACT Intervention:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: Number of Days to Meet Target Enrollment Size | Feasibility will, in part, be measured by the number of days to meet target enrollment by wave. There are a total of 3 recruitment waves. This Outcome Measure was assessed by child. | *Recruitment duration was not stratified by arm. | Posted | Number | Days | up to 3 months |
|
Adverse event data was collected during active study participation (from 4/14/2022 to 2/14/2024); any reportable events are followed to completion. Participants were assessed from enrollment to study exit, an average of six months. Caregivers were not followed for adverse events.
Per protocol, information indicating an undesirable experience with study participation was reported to PI to determine if it's associated with the study. Associated events were reported to the IRB per local guidelines: https://irb.wisc.edu/wp-content/uploads/sites/2/sites/2/2022/07/AEdecisionguidewithFDAVAupdate\_10\_31\_17.pdf. Additionally, events are documented in study files as Note-to-File. All SAEs and study-associated AEs are reported. Non-study related AEs were not collected or reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RE-PACT Intervention | Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. RE-PACT Intervention:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Coller | University of Wisconsin School of Medicine and Public Health | 608-263-9408 | rcoller@pediatrics.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2023 | Oct 30, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2022 | Mar 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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eligible caregiver/child dyads are randomized to intervention or active control
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| up to 22 months |
| Acceptability: Participant Enrollment Rate | Acceptability will in part be measured by the participant enrollment rate, or the number of participants enrolled divided by the number of participants approached + potentially eligible. This Outcome Measure was assessed by child. | up to 6 months |
| Acceptability: Categorized Reasons for Consent Refusal | Acceptability will in part be assessed by collecting potential participants reason for not consenting to the study. Reasons will be summarized in tabular form. This Outcome Measure was assessed in caregivers. | up to 6 months |
| Acceptability: Participant Drop Out Rate | Acceptability will in part be measured by the participant drop out rate. This Outcome Measure was assessed by child. | up to 6 months |
| Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan | Acceptability of the intervention will in part be measured by the participant feedback. - The number of months, on average, where participants reported use of an action plan. This Outcome Measure was assessed by dyad. | up to 6 months |
| Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others | Acceptability of the intervention will in part be measured by the participant feedback. - Number of participants reporting definite or probably recommendation of action planning to others. This Outcome Measure was assessed by dyad. | up to 6 months |
| Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others | Acceptability of the intervention will in part be measured by the participant feedback. - Number of participants reporting definite or probably recommendation of texting and clinical response to others. This Outcome Measure was assessed in dyads. | up to 6 months |
| Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done | Acceptability of the intervention will in part be measured by the participant feedback. - 'How much would you want these approaches to continue as a part of regular care after the study is done?'. This Outcome Measure was assessed in dyads. | up to 6 months |
| Acceptability: System Usability Scale - Composite Score | Acceptability of the intervention will in part be measured by composite score. The System Usability Scale is a 10-item survey scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher usability. Score range = 0 - 100. This Outcome Measure was assessed in dyads. To calculate the score: Step 1: Convert the scale into number for each of the 10 questions Strongly Disagree: 1 point Disagree: 2 points Neutral: 3 points Agree: 4 points Strongly Agree: 5 points Step 2: Calculate X = Sum of the points for all odd-numbered questions - 5 Y = 25 - Sum of the points for all even-numbered questions SUS Score = (X + Y) x 2.5 | up to 6 months |
| Fidelity: Time of Participant Enrollment in the Study | Fidelity of the intervention will in part be measured by the amount of time (in months) the participant was enrolled in the study. The target participation time is 6 months. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Number of Respiratory Action Plans Per Patient | Fidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Number of Overall Action Plans Per Patient | Fidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Coaching Visit Success Rate by Intervention Trigger | Fidelity of the intervention will in part be measured by the coaching visit success rate, which is the number of visits (at home or virtually) completed divided by the number of visits expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5 | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Text Message Response Rate | Fidelity of the intervention will in part be measured by the response rate to mHealth text messages, which is the number of texts responded divided by the number of texts expected. This Outcome Measure was assessed in dyads. | up to 6 months |
| Fidelity: Number of Participants Inappropriately Receiving Intervention | Fidelity of the intervention will in part be measured by cross-over, which is the number of participants inappropriately receiving the intervention component. This Outcome Measure was assessed in children. | up to 6 months |
| Fidelity: Data Collection Rate: Enrollment Surveys | Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads. | Baseline to 2 months |
| Fidelity: Data Collection Rate: Monthly Surveys | Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads. | up to 6 months |
| Fidelity: Data Collection Rate: Exit Surveys | Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads. | up to 6 months |
| up to 6 months |
| Total Hospital Days During Severe Respiratory Illness by Arm | Hospital days were summed by arm. | up to 6 months |
| Number of Systemic Steroid Courses | up to 6 months |
| Number of Systemic Antibiotic Courses | up to 6 months |
| Number of Respiratory Emergency Department Visits | up to 6 months |
| Child Mortality Rate | up to 6 months |
| up to 6 months |
| Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score | Capability is in part measured by the GSES sum composite score. GSES is a 10-item survey scored on a 4-point Likert scale from 1 (not true at all) to 4 (exactly true). The sum composite score ranges from 10 - 40, with higher scores indicating higher efficacy. | up to 6 months |
| Family Experiences With Care Coordination (FECC): Care Coordination Question Set | Opportunity is assessed via the FECC score, using measure specifications for each item(s). The Care Coordination Question set assesses the statement "Care Coordinator Was Knowledgeable, Supportive and Advocated for Child's Needs" on a scale from 0 - 100 with
This Outcome Measure was assessed in dyads. | up to 6 months |
| Average Confidence Responses Reported by mHealth Texting | Motivation is assessed by the confidence response to weekly texting and averaged over time by participant. (1-10 with higher scores indicating increased confidence). This Outcome Measure was assessed in dyads. | up to 6 months |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| BG001 | RE-PACT Intervention: Caregiver | Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. RE-PACT Intervention:
|
| BG002 | Active Control (AC): Child | AC subjects will receive usual comprehensive medical care and coordination. |
| BG003 | Active Control (AC): Caregiver | AC subjects will receive usual comprehensive medical care and coordination. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups | Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Missing data due to non-response | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Primary | Feasibility: Median Number of Days Between Randomization and Intervention Activities | Feasibility will, in part, be measured by the number of days between randomization and (time zero) intervention activities. This Outcome Measure was assessed by child. | Posted | Median | Inter-Quartile Range | Days | up to 3 months |
|
|
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| Primary | Feasibility: Mean Number of Minutes Logged for Action Planning | Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child. | Posted | Mean | Standard Deviation | Minutes | up to 6 months |
|
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| Primary | Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching | Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child. | Posted | Mean | Standard Deviation | Minutes | up to 6 months |
|
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| Primary | Feasibility: Mean Number of Intervention Triggers Per Patient | Feasibility will, in part, be measured by the number of intervention triggers per patient (annualized), including respiratory and non-respiratory triggers. This Outcome Measure was assessed by child. | Posted | Mean | Standard Deviation | Intervention Triggers | up to 6 months |
|
|
|
| Primary | Feasibility: Incidence of Data Infrastructure Issues | Feasibility will in part be measured by the presence of necessary data infrastructure issues. This is a measure of the presence of complete data collection, between 2 sites, data use agreements and Institutional Review Board reliance. This outcome includes any events that occur over the study duration. | Number analyzed represents the number of participants by wave. | Posted | Number | Data Infrastructure Issues | up to 22 months |
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| Primary | Acceptability: Participant Enrollment Rate | Acceptability will in part be measured by the participant enrollment rate, or the number of participants enrolled divided by the number of participants approached + potentially eligible. This Outcome Measure was assessed by child. | The number of participants analyzed must reflect the number of participants approached in addition to those consented. Enrollment rate was not stratified by arm. | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Acceptability: Categorized Reasons for Consent Refusal | Acceptability will in part be assessed by collecting potential participants reason for not consenting to the study. Reasons will be summarized in tabular form. This Outcome Measure was assessed in caregivers. | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Acceptability: Participant Drop Out Rate | Acceptability will in part be measured by the participant drop out rate. This Outcome Measure was assessed by child. | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan | Acceptability of the intervention will in part be measured by the participant feedback. - The number of months, on average, where participants reported use of an action plan. This Outcome Measure was assessed by dyad. | Posted | Mean | Standard Deviation | Months | up to 6 months |
|
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| Primary | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others | Acceptability of the intervention will in part be measured by the participant feedback. - Number of participants reporting definite or probably recommendation of action planning to others. This Outcome Measure was assessed by dyad. | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others | Acceptability of the intervention will in part be measured by the participant feedback. - Number of participants reporting definite or probably recommendation of texting and clinical response to others. This Outcome Measure was assessed in dyads. | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done | Acceptability of the intervention will in part be measured by the participant feedback. - 'How much would you want these approaches to continue as a part of regular care after the study is done?'. This Outcome Measure was assessed in dyads. | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Acceptability: System Usability Scale - Composite Score | Acceptability of the intervention will in part be measured by composite score. The System Usability Scale is a 10-item survey scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher usability. Score range = 0 - 100. This Outcome Measure was assessed in dyads. To calculate the score: Step 1: Convert the scale into number for each of the 10 questions Strongly Disagree: 1 point Disagree: 2 points Neutral: 3 points Agree: 4 points Strongly Agree: 5 points Step 2: Calculate X = Sum of the points for all odd-numbered questions - 5 Y = 25 - Sum of the points for all even-numbered questions SUS Score = (X + Y) x 2.5 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
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| Primary | Fidelity: Time of Participant Enrollment in the Study | Fidelity of the intervention will in part be measured by the amount of time (in months) the participant was enrolled in the study. The target participation time is 6 months. This Outcome Measure was assessed in children. | Posted | Mean | Standard Deviation | Months | up to 6 months |
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| Primary | Fidelity: Number of Respiratory Action Plans Per Patient | Fidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1. This Outcome Measure was assessed in children. | Posted | Mean | Standard Deviation | Respiratory Action Plans | up to 6 months |
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| Primary | Fidelity: Number of Overall Action Plans Per Patient | Fidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1. This Outcome Measure was assessed in children. | Posted | Mean | Standard Deviation | Overall Action Plans | up to 6 months |
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| Primary | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Fidelity of the intervention will in part be measured by the coaching visit success rate, which is the number of visits (at home or virtually) completed divided by the number of visits expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | Rows are stratified by trigger type. There are 26 triggers total, of which n = 9 are due to caregiver confidence, n = 9 are due to hospital discharge, n = 4 are due to caregiver contact, and n = 4 are due to multiple triggers. | Posted | Count of Units | Intervention triggers | up to 6 months | Intervention triggers | Intervention triggers |
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| Primary | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5 | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | More follow-ups were completed than expected. | Posted | Number | Follow-Ups | up to 6 months |
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| Primary | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | More follow-ups were completed than expected. | Posted | Number | Follow-Ups | up to 6 months |
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| Primary | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | More follow-ups were completed than expected. | Posted | Number | Follow-Ups | up to 6 months |
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| Primary | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers | Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children. | More follow-ups were completed than expected. | Posted | Number | Follow-Ups | up to 6 months |
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| Primary | Fidelity: Text Message Response Rate | Fidelity of the intervention will in part be measured by the response rate to mHealth text messages, which is the number of texts responded divided by the number of texts expected. This Outcome Measure was assessed in dyads. | Posted | Number | Text messages | up to 6 months |
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| Primary | Fidelity: Number of Participants Inappropriately Receiving Intervention | Fidelity of the intervention will in part be measured by cross-over, which is the number of participants inappropriately receiving the intervention component. This Outcome Measure was assessed in children. | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Fidelity: Data Collection Rate: Enrollment Surveys | Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads. | *Data collection was not stratified by arm. | Posted | Number | Completed Enrollment Surveys | Baseline to 2 months |
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| Primary | Fidelity: Data Collection Rate: Monthly Surveys | Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads. | Posted | Number | Completed Monthly Surveys | up to 6 months | Monthly surveys | Monthly surveys |
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| Primary | Fidelity: Data Collection Rate: Exit Surveys | Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads. | *Data collection was not stratified by arm. | Posted | Number | Completed Exit Surveys | up to 6 months |
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| Secondary | Incidence of Respiratory Diagnosis Requiring Hospitalization | Severe respiratory illness, defined as respiratory diagnoses requiring hospitalization. Respiratory diagnoses includes discharge diagnosis of any of the following: asthma, pneumonia (community or hospital acquired), bronchiolitis, influenza, upper or lower respiratory tract infection, tracheitis, aspiration pneumonia/pneumonitis, chronic lung disease, respiratory failure. - Number of children with at least 1 severe respiratory illness | Posted | Count of Participants | Participants | up to 6 months |
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| Secondary | Total Hospital Days During Severe Respiratory Illness by Arm | Hospital days were summed by arm. | Posted | Number | Hospital Days | up to 6 months |
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| Secondary | Number of Systemic Steroid Courses | Posted | Count of Participants | Participants | up to 6 months |
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| Secondary | Number of Systemic Antibiotic Courses | Posted | Count of Participants | Participants | up to 6 months |
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| Secondary | Number of Respiratory Emergency Department Visits | Posted | Number | Respiratory ED Visits | up to 6 months |
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| Secondary | Child Mortality Rate | Posted | Count of Participants | Participants | up to 6 months |
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| Other Pre-specified | Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score | Capability is in part measured by the FCAT mean composite score,. FCAT is a 10-item survey to assess the caregiver's challenges on the day it is taken, scored on a 5 point likert scale from 1 (disagree strongly) to 5 (agree strongly). The mean composite score ranges from 1 - 5 with higher scores indicating higher activation. Activation of a family member refers to their desire, knowledge, confidence, and skills that can inform engagement in healthcare. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
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| Other Pre-specified | Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score | Capability is in part measured by the GSES sum composite score. GSES is a 10-item survey scored on a 4-point Likert scale from 1 (not true at all) to 4 (exactly true). The sum composite score ranges from 10 - 40, with higher scores indicating higher efficacy. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
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| Other Pre-specified | Family Experiences With Care Coordination (FECC): Care Coordination Question Set | Opportunity is assessed via the FECC score, using measure specifications for each item(s). The Care Coordination Question set assesses the statement "Care Coordinator Was Knowledgeable, Supportive and Advocated for Child's Needs" on a scale from 0 - 100 with
This Outcome Measure was assessed in dyads. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
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| Other Pre-specified | Average Confidence Responses Reported by mHealth Texting | Motivation is assessed by the confidence response to weekly texting and averaged over time by participant. (1-10 with higher scores indicating increased confidence). This Outcome Measure was assessed in dyads. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
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| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Active Control (AC) | AC subjects will receive usual comprehensive medical care and coordination. | 0 | 24 | 1 | 24 | 0 | 24 |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Wave 3 |
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| Ineligible: Not enrolled in a complex care program |
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| Ineligible: Moving out of the area |
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| Ineligible: Does not meet English or Spanish language proficiency |
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| Recruitment completed before enrollment |
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| Not interested in the intervention |
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| Not interested in research |
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| Too busy |
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| Unable to contact |
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| Clinical response NOT completed for trigger |
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| Trigger: Hospital Discharge |
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| Trigger: Caregiver calls or messages complex care team |
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| Trigger: Multiple triggers |
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