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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Parent caregivers of children with chronic conditions who require life-saving technology such as mechanical ventilation or feeding tubes must maintain a high level of vigilance 24 hours a day, 7 days a week. They usually provide a majority of their children's care and are often overwhelmed by the caregiving demands thus neglect health promotion behaviors that result in a deterioration of their own mental and physical health. The goal of this study is to test a cognitive-behavioral resourcefulness intervention that will improve these caregivers' mental and physical health and health promotion behaviors while they continue to provide vital care for these vulnerable children.
Parent caregivers of children who require life-saving technology such as mechanical ventilation or feeding tubes must maintain a high level of vigilance 24 hours a day, 7 days a week. They report greater levels of stress, compromised self-management behaviors and poorer psychological and physical health than other caregiver groups which dramatically increases their mortality risk. Technology-dependent children (approximately 600,000) are among the sickest and most vulnerable subset of children with complex chronic conditions in the United States. They comprise 20% of all children discharged from the hospital to home, yet account for 61% of healthcare spending for children, up to $110 billion annually. Despite the adverse consequences for caregivers, there are no interventions to meet their specific needs. Resourcefulness Training, (cognitive-behavioral self-management intervention) has been shown to improve psychological and physical outcomes, mediate the effects of stress, and enhance the care provided to care-recipients. A Resourcefulness Training Intervention (RTI) will be tested in a randomized trial against an attention control group. The RTI includes face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills, ongoing web access to the RTI video and video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life, 4 weeks of skills' reinforcement using daily log, weekly phone calls for the first 4 weeks, and booster sessions at 2 and 4 months post enrollment. The Attention Control group will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care. The aims of the study are to: 1) Determine whether the RTI versus Attention Control improves psychological (mental HRQoL depressive cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (physical HRQoL, chronic stress [hair cortisol]) over 9 months in parents of technology-dependent children, after controlling for covariates (parent race/ethnicity and gender, family income, and children's functional status, type of technology). 2) Determine whether changes in psychological and physical outcomes are mediated by changes in parents' levels of resourcefulness based on intervention condition. 3) Compare self-management behavior (sleep, positive health practices) over 9 months in parents who received RTI versus Attention Control. 4) Explore whether resourcefulness is a mediator between intervention condition and self-management behaviors controlling for baseline self-management behavior over 9 months. 5) Explore the relationship between self-management behavior and parent psychological and physical outcomes based on intervention condition. Our study will be the first to test a cognitive-behavioral RTI for this caregiver population. 6) Compare target children's ER visits, hospital days over 9 months based on parent intervention condition. If shown to be efficacious, it can be replicated with other caregivers of children with complex chronic conditions with strong potential for translation into practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | No Intervention | The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns | |
| Resourcefulness Training Intervention© | Experimental | The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resourcefulness Training© | Behavioral | The intervention includes self-help and help-seeking skills. |
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| Measure | Description | Time Frame |
|---|---|---|
| Psychological Outcome- Health Related Quality of Life | Mental Health Related Quality of Life (The Patient-Reported Outcomes Measurement Information System [PROMIS] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Mental Health (GMH) score converted to a T-Score metric - produces a physical and a mental health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept being measured or better mental health. | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
| Depressive Cognitions | Screening Measure for Early Detection of Depressive Symptoms: The Depressive Cognition Scale. Measures depressive cognitions and negative thoughts that may lead to clinical depression. Eight (8) Items. Score Range: 0 - 40. Higher scores indicating more depressive cognitions. | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
| Physical Outcome | (The Patient-Reported Outcomes Measurement Information System [PROMIS] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Physical Health (GPH) score converted to a T-Score metric - produces a physical health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Higher T-score means better physical health. | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
| Self-Management- Sleep- Subjective | Appraised Sleep Quality (Pittsburgh Sleep Quality Index), Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality Index (PSQI). Assesses sleep quality and disturbances over a l-month time interval. Nineteen (19) items are grouped into seven component scores, each weighted equally on a 0-3 scale. Score Range (Global PSQI Score) is 0-21. Higher scores indicate worse sleep quality. Sub Scales are summed |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Technology-Dependent Children With ER Visits | Number of Technology-Dependent Children with ER Visits over the time period the parent was enrolled and participating in the study from review of the children's charts. | Up to 9 months |
| Number of Technology-Dependent Children With Rehospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
- Parents of children with a cancer diagnosis due to the short term use of technology following initial diagnosis and treatment
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| Name | Affiliation | Role |
|---|---|---|
| Valerie A. Toly, PhD, RN | Frances Payne Bolton School of Nursing, Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106-5065 | United States |
Resource Sharing Plan: We support the principles, responsibilities and oversight of data sharing as articulated in the Final NIH Statement on Sharing Research Data (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). Once all data are collected, the research team will work to establish a database for the purpose of implementation of these standards, but with an emphasis upon the safeguarding of patient privacy, maintaining scientific integrity, and ensuring database privacy and security. Our goals will be to support the NIH intent of promoting dissemination of research findings and reagents to benefit NIH researchers country-wide and to promote rapid dissemination of clinical research findings. The data will be shared once all Human Subject identifiers are removed and preliminary analyses have been completed and collaborative ventures will be explored with the other investigators.
The data will be shared once all Human Subject identifiers are removed and preliminary analyses have been completed and collaborative ventures will be explored with the other investigators.
Must enter into data use agreement with Case Western Reserve University and the investigators.
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There were 5 participants who signed the consent form but did not complete the baseline surveys and therefore they were not randomized and therefore not analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control | The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns. |
| FG001 | Resourcefulness Training Intervention© | The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing. Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns |
| BG001 | Resourcefulness Training Intervention© |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Psychological Outcome- Health Related Quality of Life | Mental Health Related Quality of Life (The Patient-Reported Outcomes Measurement Information System [PROMIS] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Mental Health (GMH) score converted to a T-Score metric - produces a physical and a mental health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept being measured or better mental health. | The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
|
9 months
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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 | Attention Control | The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns. |
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A majority of our study recruitment, enrollment, and data collection occurred during the Pandemic (2020-2021) therefore the protocol was modified to comply with the lockdown public health measures and the IRB mandate. All components of the study were conducted virtually using an institutional review board (IRB) approved videochat platform, REDCap, telephone, and text beginning in June 2020.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Boebel Toly, PhD, RN, CPNP-PC, FAAN | Frances Payne Bolton School of Nursing, Case Western Reserve University | 216-534-5844 | vab@case.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 | Nov 8, 2022 | Mar 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The proposed study is a longitudinal (9-month) randomized controlled trial (RCT) in which primary caregiver parents of technology-dependent children will be randomly assigned to one of two study arms: (1) The Attention Control arm and (2) The Resourcefulness Training(c) arm.
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Data collectors and participants will be blinded to group assignment.
| Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline |
| Positive Health Practices | Personal Lifestyle Questionnaire- Positive Health Practices Personal Lifestyle Questionnaire (PLQ). Measures the positive health practices of exercise, substance use, nutrition, relaxation, safety, and health promotion. Twenty-four (24) items 4-point summated rating scale with a range of possible scores from 24 to 96 Higher scores reflect the practice of more health behaviors. Total scores are reported. | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
| Depressive Symptoms | "Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symptoms "Patient Reported Outcomes Measurement Information System (PROMIS)Short Form Version 1.0 - Depression 8a. Assess self-reported negative mood , views of self , social cognition, and decreased positive affect and engagement." Eight (8) Items. Score Range: 5 (Min)-40 (Max). Total Score is reported. The score is converted to a T-Score metric. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept (depression) being measured thus a T-score of 60 is one standard deviation worse related to the concept of depression than average. | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
Number of Technology-Dependent Children with Rehospitalizations over the time period the parent was enrolled and participating in the study from review of the children's charts. |
| Up to 9 months |
| Parent no longer eligible- child not living at home |
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| Unable to contact to complete the intervention. |
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The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing. Resourcefulness Training©: The intervention includes self-help and help-seeking skills. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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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| Duration of Caregiving for Technology-Dependent Child | Number of months the parent has been caring for the child since they became dependent on medical technology. | Mean | Standard Deviation | months |
|
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
| OG001 | Resourcefulness Training Intervention© | The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing. Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills. |
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| Primary | Depressive Cognitions | Screening Measure for Early Detection of Depressive Symptoms: The Depressive Cognition Scale. Measures depressive cognitions and negative thoughts that may lead to clinical depression. Eight (8) Items. Score Range: 0 - 40. Higher scores indicating more depressive cognitions. | The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
|
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| Primary | Physical Outcome | (The Patient-Reported Outcomes Measurement Information System [PROMIS] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Physical Health (GPH) score converted to a T-Score metric - produces a physical health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Higher T-score means better physical health. | The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
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| Primary | Self-Management- Sleep- Subjective | Appraised Sleep Quality (Pittsburgh Sleep Quality Index), Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality Index (PSQI). Assesses sleep quality and disturbances over a l-month time interval. Nineteen (19) items are grouped into seven component scores, each weighted equally on a 0-3 scale. Score Range (Global PSQI Score) is 0-21. Higher scores indicate worse sleep quality. Sub Scales are summed | The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline |
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| Primary | Positive Health Practices | Personal Lifestyle Questionnaire- Positive Health Practices Personal Lifestyle Questionnaire (PLQ). Measures the positive health practices of exercise, substance use, nutrition, relaxation, safety, and health promotion. Twenty-four (24) items 4-point summated rating scale with a range of possible scores from 24 to 96 Higher scores reflect the practice of more health behaviors. Total scores are reported. | The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
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| Primary | Depressive Symptoms | "Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symptoms "Patient Reported Outcomes Measurement Information System (PROMIS)Short Form Version 1.0 - Depression 8a. Assess self-reported negative mood , views of self , social cognition, and decreased positive affect and engagement." Eight (8) Items. Score Range: 5 (Min)-40 (Max). Total Score is reported. The score is converted to a T-Score metric. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept (depression) being measured thus a T-score of 60 is one standard deviation worse related to the concept of depression than average. | The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline |
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| Secondary | Number of Technology-Dependent Children With ER Visits | Number of Technology-Dependent Children with ER Visits over the time period the parent was enrolled and participating in the study from review of the children's charts. | Posted | Mean | Standard Deviation | Number of ER visits | Up to 9 months |
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| Secondary | Number of Technology-Dependent Children With Rehospitalizations | Number of Technology-Dependent Children with Rehospitalizations over the time period the parent was enrolled and participating in the study from review of the children's charts. | Posted | Mean | Standard Deviation | Number of rehospitalizations | Up to 9 months |
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| 0 |
| 97 |
| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | Resourcefulness Training Intervention© | The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing. Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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