- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877680
Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study (T1DoingWell)
Development and Pilot of a Strengths-Based Behavioral mHealth Intervention to Promote Resilience in Adolescents With Type 1 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of type 1 diabetes according to American Diabetes Association criteria for at least 6 months
- Treated for type 1 diabetes at Texas Children's Hospital Diabetes Care Center
- Parent and adolescent fluency in English
- Parent has mobile device with data plan
Exclusion Criteria:
- Serious medical, cognitive, or mental health comorbidity in parent or adolescent that would preclude ability to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.
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Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors
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No Intervention: Usual Care
Usual diabetes care and study-related data collection, without use of app during the study period.
They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Study Design - Recruitment Rate
Time Frame: Immediately following enrollment (baseline timepoint)
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Recruitment data measured by percent of recruited families that enrolled in study.
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Immediately following enrollment (baseline timepoint)
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Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week
Time Frame: 3-4 months after enrollment (follow-up timepoint)
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Feasibility of the app measured by percentage of participants that engaged with or used the app at least twice a week during the intervention period.
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3-4 months after enrollment (follow-up timepoint)
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Acceptability of T1Doing Well App (Survey)
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Participants in the intervention arm completed the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE), a measure of the users' perceived usefulness of, satisfaction with, and ease of use of a particular technology.
The item scale ranges from the minimum to maximum possible score is 1-7, with a higher score representing a better outcome.
Acceptability measured as percentage of participants who selected a score of at least 4 (out of 7) on the item "I am satisfied with it," indicating it was at least somewhat acceptable.
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3-4 months after baseline (follow-up timepoint)
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Acceptability - Number of Participants That Felt The Intervention Was Well-Received
Time Frame: 3-4 months after baseline (follow-up timepoint)
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The number of participants that felt the intervention was well-received was collected for Adolescents and Parents.
To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team.
We coded these data qualitatively and classified them as Positive, Negative, or Neutral.
Positive responses indicate the intervention was well-received.
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3-4 months after baseline (follow-up timepoint)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Objective measurement of adherence to diabetes regimen measured by blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads.
The average daily frequency was calculated over the 14 days prior to the assessment at the baseline visit.
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3-4 months after baseline (follow-up timepoint)
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Glycemic Control - HbA1c
Time Frame: 3-4 months after baseline (follow-up timepoint)
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At the time of this study, the American Diabetes Association generally recommended an HbA1c target of <7.0% (it was <7.5% at the time this study took place, for individuals younger than 18 years.
The especific target varies depending on the individual).
The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%.
HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values were extracted from the medical record at each clinic visit during the study period.
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3-4 months after baseline (follow-up timepoint)
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Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Diabetes-specific family impact was measured using the Diabetes Family Impact Scale (DFIS), a 15-item measure of the impact of diabetes on family members' activities and relationships.
The scale range from the minimum to maximum possible score is 0-100.
A higher score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Family impact was measured using The Pediatric Quality of Life Family Impact Module (Peds QL-FI), a 36-item measure of the impact of parenting a child with a chronic medical condition on family functioning and parent QOL.
The scale range from the minimum to the maximum score is 0-100.
A higher score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Family Communication - Helping for Health Inventory (HHI), Parent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Family communication was measured by the parent-report Helping for Health Inventory (HHI), a 15-item questionnaire assessing perceptions of parental help around the teen's diabetes management.
The scale range from the minimum to maximum possible score is 15-75.
A lower score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Family Communication - Helping for Health Inventory (HHI), Adolescent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Family communication was measured using the adolescent-report Helping for Health Inventory (HHI), a 15-item questionnaire assessing perceptions of parental help around the teen's diabetes management.
The scale range from the minimum to maximum possible score is 15-75.
A lower score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Diabetes Family Conflict Scale-Revised (DFCS), Parent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Family conflict was measured using the Diabetes Family Conflict Scale - Revised (DFCS), a measure of diabetes-specific conflict in families with adolescents with type 1 diabetes.
The scale range from the minimum to maximum possible score is 19-57.
A lower score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Family conflict was measured using the Diabetes Family Conflict Scale - Revised (DFCS), a measure of diabetes-specific conflict in families with adolescents with type 1 diabetes.
The scale range from the minimum to maximum possible score is 19-57.
A lower score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Problem Areas in Diabetes-Teen (PAID-T), Parent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Diabetes burden was measured using the Problem Areas in Diabetes (PAID-T) parent-report, a measure of how bothersome day-to-day problems are for parents of adolescents with type 1 diabetes.
The scale range from the minimum to maximum possible score is 26-156.
A lower score represents better a outcome.
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3-4 months after baseline (follow-up timepoint)
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Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Diabetes burden was measured using the Problem Areas in Diabetes-Teen (PAID-T) self-report, a measure of how bothersome day-to-day problems are for adolescents with type 1 diabetes.
The scale range from the minimum to maximum possible score is 26-156.
A lower score represents better a outcome.
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3-4 months after baseline (follow-up timepoint)
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Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Parent-report of adolescent self-management was measured using the 24-item Diabetes Self-Management Profile Self-Report (DSMP).
Parents completed the version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items).
The scale range from the minimum to maximum possible score is 0-86.
A higher score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Self-management was measured using the Self-Care Inventory-Revised (SCI-R), a 15-item measure of the frequency that adolescents engage in diabetes management behaviors on a 5-point scale from Never to Always.
The scale range from the minimum to maximum possible score is 5-75.
A higher score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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The Diabetes Strengths and Resilience measure is a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges.
The scale range from the minimum to maximum possible score is 0-48.
A higher value on this scale represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent Self-report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Adolescent quality of life was measured using the Monitoring Individual Needs in Diabetes Youth Questionnaire (MIND-Youth/MY-Q), a 33-item measure of diabetes-specific health-related QOL.
The scale range from the minimum to maximum possible score is 0-100.
A higher score represents a better outcome.
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3-4 months after baseline (follow-up timepoint)
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Parent-Adolescent Relationship Intervention Process Measure, Adolescent Report
Time Frame: 3-4 months after baseline (follow-up timepoint)
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Adolescents answered 3 items adapted from the Parent-Youth Relationship Index of the National Longitudinal Study of Youth-1997, a measure of parent-adolescent relationship quality. Item scale ranges from minimum to maximum score of 1-5 for each item, with a higher score indicating a better outcome. Intervention process from baseline to follow-up was analyzed using a general linear mixed model, using the item "How often does he/she praise you for doing well?" Time since first baseline clinic visit was computed and analyzed using a mixed model with time, arm, and the time-arm interaction term. The outcome measure data are reported as slopes by arm. *NOTE: Intervention process measures were administered biweekly, and we are reporting the calculated mean change per day with 95% confidence intervals. |
3-4 months after baseline (follow-up timepoint)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marisa E Hilliard, PhD, Baylor College of Medicine and Texas Children's Hospital
Publications and helpful links
General Publications
- Hilliard ME, Cao VT, Eshtehardi SS, Minard CG, Saber R, Thompson D, Karaviti LP, Anderson BJ. Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Nov;22(11):835-845. doi: 10.1089/dia.2020.0048. Epub 2020 May 22.
- Hilliard ME, Eshtehardi SS, Minard CG, Saber R, Thompson D, Karaviti LP, Rojas Y, Anderson BJ. Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2018 Mar 13;7(3):e77. doi: 10.2196/resprot.9147.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-37311
- 1R21DK107951 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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