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The purpose of this proposal is to integrate family-centered self-management strategies with mobile health (mHealth) technology to improve reach, self-management behaviors, and child and caregiver physical and psychosocial symptoms and quality of life. Specifically, the investigators propose to conduct feasibility testing of SMYLS, which has been adapted based on user feedback in the first phase of this study. First the investigators will work with the Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and recruit families with children with sickle cell disease (SCD) in the community, statewide. Next, the investigators will test the feasibility of the intervention with 30 dyads of children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group intervention arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice Crisis Alert V2 | Behavioral | Intervention consists of a mHealth app delivered via smartphone |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of Recruitment | Number of weeks required to recruit 30 participants. | Assessed each week over a period of 6 months, cumulative data up to 6 months is reported. |
| Participant Adherence to Intervention | Number of participants who used the intervention (mHealth application) from baseline to mid-intervention, from mid-intervention to end-of-intervention, and from end-of-intervention to follow-up, assessed by number of participants who logged into and used the app, stored in the app's back end database. | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
| Acceptability of Intervention | Number of participants reporting problems with the intervention (mHealth app) per week. | Assessed each week over a period of 6 months, cumulative data up to 6 months is reported. |
| Participant Adherence to Intervention | number of participants who accessed the educational component of intervention, assessed using back end app use database | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
| Participant Adherence to Intervention | Number of participants who accessed the symptom monitoring component of the intervention, assessed using the app back end database | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
| Participant Adherence to Intervention | number of participants who sent messages to nurse practitioner | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Mean Pain Score Rating From Baseline to End-of-intervention | Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Pediatric Short Form 8a: Change in score at 12 weeks minus baseline. Raw scores range from 0 - 32, with 0 being the lowest pain rating and 32 the highest pain rating. Any decrease in mean difference between scores = improved | baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Receiving mHealth Intervention | This was a single-arm study; all participants received the intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | This was a single-arm study; all participants received the 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, Continuous | Mean |
| 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 | Rates of Recruitment | Number of weeks required to recruit 30 participants. | Posted | Number | weeks | Assessed each week over a period of 6 months, cumulative data up to 6 months is reported. |
|
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The duration of study participation; 6 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 | Intervention Group | This was a single-arm study; all participants received the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaso-occlusive crisis | Blood and lymphatic system disorders | Non-systematic Assessment | Participants were hospitalized for occurrence of vaso-occlusive crisis |
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Limitations of this feasibility study included technical difficulties with the app, leading to an inability to accurately assess medication adherence data and measurement issues with the clinic appointment attendance. We were unable to assess these additional outcome measures with accuracy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shannon Phillips, PhD, RN, Associate Professor | Medical University of South Carolina College of Nursing | 843-792-9379 | phillipss@musc.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 | Sep 25, 2018 | Feb 20, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 28, 2017 | Feb 20, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention | Self-efficacy for Managing Chronic Disease 6-item scale. Scores for each item range from 1 - 10 with 1 indicating lower confidence/self-efficacy and 10 indicating higher confidence/self-efficacy. Scores for each item are averaged for the mean total score. Change in score at 12 weeks minus baseline. Any increase in difference in mean scores = improved | baseline, 12 weeks |
| Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention | Pediatric Quality of Life Inventory (Peds QL): Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference between mean scores = improved | baseline, 12 weeks |
| Difference in Mean Scores for Fatigue From Baseline to End-of-intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Pediatric Short Form 10a: Raw Scores range from 0 - 40 with 0 being the least amount of fatigue and 40 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved | baseline, 12 weeks |
| Difference in Mean Scores for Anxiety From Baseline to End-of-intervention | Patient Reported Outcomes Measurement System (PROMIS) Pediatric Short Form Anxiety 8a: Raw Scores range from 0 - 32, with 0 being the lowest anxiety rating and 32 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved | baseline, 12 weeks |
| Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention | Patient Reported Outcomes Measurement System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved | baseline,12 weeks |
| Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention | Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity Pediatric 3a. Raw scores range from 3 - 15, with 3 being the lowest pain intensity rating and 15 being the highest pain intensity rating. Change in score at 12 weeks minus baseline. Any decrease in mean difference between scores = improved | baseline, 12 weeks |
| Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention | Pediatric Quality of Life Inventory (Peds QL) with SCD module: Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference between mean scores = improved | baseline, 12 weeks |
| Clinic Appointment Attendance | Number of missed clinic appointments at baseline compared to 12 weeks | 12 weeks |
| Home Medication Administration | Adherence to home medications, measured by number of medications marked as taken in the app database. | 12 weeks |
| years |
|
| 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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| Parent/caregiver type | Count of Participants | Participants |
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| Parent/caregiver employment status | Count of Participants | Participants |
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| Parent/caregiver education level | Count of Participants | Participants |
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| Parent/caregiver marital status | Count of Participants | Participants |
|
| household size | Mean | Standard Deviation | number of people |
|
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| Primary | Participant Adherence to Intervention | Number of participants who used the intervention (mHealth application) from baseline to mid-intervention, from mid-intervention to end-of-intervention, and from end-of-intervention to follow-up, assessed by number of participants who logged into and used the app, stored in the app's back end database. | Posted | Number | participants | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
|
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| Primary | Acceptability of Intervention | Number of participants reporting problems with the intervention (mHealth app) per week. | Posted | Count of Participants | Participants | Assessed each week over a period of 6 months, cumulative data up to 6 months is reported. |
|
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| Primary | Participant Adherence to Intervention | number of participants who accessed the educational component of intervention, assessed using back end app use database | Posted | Number | participants | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
|
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| Primary | Participant Adherence to Intervention | Number of participants who accessed the symptom monitoring component of the intervention, assessed using the app back end database | Posted | Number | participants | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
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| Primary | Participant Adherence to Intervention | number of participants who sent messages to nurse practitioner | Posted | Number | participants | baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months |
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| Secondary | Difference in Mean Pain Score Rating From Baseline to End-of-intervention | Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Pediatric Short Form 8a: Change in score at 12 weeks minus baseline. Raw scores range from 0 - 32, with 0 being the lowest pain rating and 32 the highest pain rating. Any decrease in mean difference between scores = improved | 20 participants retained to 12 weeks (end-of-intervention) for analysis | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
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| Secondary | Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention | Self-efficacy for Managing Chronic Disease 6-item scale. Scores for each item range from 1 - 10 with 1 indicating lower confidence/self-efficacy and 10 indicating higher confidence/self-efficacy. Scores for each item are averaged for the mean total score. Change in score at 12 weeks minus baseline. Any increase in difference in mean scores = improved | 20 participants retained to 12 weeks | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
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| Secondary | Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention | Pediatric Quality of Life Inventory (Peds QL): Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference between mean scores = improved | 20 participants retained to end-of-intervention for analysis | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
|
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| Secondary | Difference in Mean Scores for Fatigue From Baseline to End-of-intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Pediatric Short Form 10a: Raw Scores range from 0 - 40 with 0 being the least amount of fatigue and 40 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved | 20 participants retained to end-of-intervention for analysis | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
|
|
| Secondary | Difference in Mean Scores for Anxiety From Baseline to End-of-intervention | Patient Reported Outcomes Measurement System (PROMIS) Pediatric Short Form Anxiety 8a: Raw Scores range from 0 - 32, with 0 being the lowest anxiety rating and 32 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved | 20 participants retained to end-of-intervention for analysis | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
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| Secondary | Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention | Patient Reported Outcomes Measurement System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved | 20 participants retained to end-of-intervention for analysis | Posted | Mean | 95% Confidence Interval | scores on scale | baseline,12 weeks |
|
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| Secondary | Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention | Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity Pediatric 3a. Raw scores range from 3 - 15, with 3 being the lowest pain intensity rating and 15 being the highest pain intensity rating. Change in score at 12 weeks minus baseline. Any decrease in mean difference between scores = improved | 20 participants retained to end-of-intervention | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
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| Secondary | Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention | Pediatric Quality of Life Inventory (Peds QL) with SCD module: Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference between mean scores = improved | 20 participants retained to end-of-intervention for analysis | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
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| Secondary | Clinic Appointment Attendance | Number of missed clinic appointments at baseline compared to 12 weeks | Limitations of this feasibility study included issues with the wording and participant interpretation of clinic appointment attendance questions, leading to an inability to accurately assess clinic appointment attendance. | Posted | 12 weeks |
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| Secondary | Home Medication Administration | Adherence to home medications, measured by number of medications marked as taken in the app database. | Limitations of this feasibility study included technical difficulties with the app, leading to an inability to accurately assess home medication administration. | Posted | 12 weeks |
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| 0 |
| 30 |
| 2 |
| 30 |
| 0 |
| 30 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
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