Trial Outcomes & Findings for Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study (NCT NCT02877680)
NCT ID: NCT02877680
Last Updated: 2020-09-24
Results Overview
Recruitment data measured by percent of recruited families that enrolled in study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Immediately following enrollment (baseline timepoint)
Results posted on
2020-09-24
Participant Flow
Recruited from diabetes clinics at Texas Children's Hospital.
Of 84 families consented, 2 families did not complete baseline questionnaires and were not randomized (1 withdrew due to time demands, 1 moved to another care institution). Of the remaining 82 families, 2 completed baseline questionnaires but were never randomized because they never completed a study visit, resulting in a randomized sample of n=80.
Participant milestones
| Measure |
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.
T1Doing Well: 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
25
|
|
Overall Study
COMPLETED
|
54
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
T1Doing Well: 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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
n represents number with complete data.
Baseline characteristics by cohort
| Measure |
Intervention
n=55 Participants
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.
T1Doing Well: 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
|
Usual Care
n=25 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.4 years
STANDARD_DEVIATION 1.5 • n=55 Participants
|
15.1 years
STANDARD_DEVIATION 1.4 • n=25 Participants
|
15.3 years
STANDARD_DEVIATION 1.5 • n=80 Participants
|
|
Sex: Female, Male
Adolescent · Female
|
33 Participants
n=55 Participants
|
14 Participants
n=25 Participants
|
47 Participants
n=80 Participants
|
|
Sex: Female, Male
Adolescent · Male
|
22 Participants
n=55 Participants
|
11 Participants
n=25 Participants
|
33 Participants
n=80 Participants
|
|
Sex: Female, Male
Parent · Female
|
44 Participants
n=55 Participants
|
21 Participants
n=25 Participants
|
65 Participants
n=80 Participants
|
|
Sex: Female, Male
Parent · Male
|
11 Participants
n=55 Participants
|
4 Participants
n=25 Participants
|
15 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Adolescent · Hispanic or Latino
|
14 Participants
n=55 Participants
|
1 Participants
n=25 Participants
|
15 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Adolescent · Unknown or Not Reported
|
0 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Parent · Hispanic or Latino
|
14 Participants
n=55 Participants
|
1 Participants
n=25 Participants
|
15 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Parent · Not Hispanic or Latino
|
40 Participants
n=55 Participants
|
24 Participants
n=25 Participants
|
64 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Parent · Unknown or Not Reported
|
1 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Adolescent · American Indian or Alaska Native
|
0 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Adolescent · Asian
|
1 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Adolescent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Adolescent · Black or African American
|
8 Participants
n=55 Participants
|
2 Participants
n=25 Participants
|
10 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Adolescent · White
|
39 Participants
n=55 Participants
|
20 Participants
n=25 Participants
|
59 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Adolescent · More than one race
|
4 Participants
n=55 Participants
|
3 Participants
n=25 Participants
|
7 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Adolescent · Unknown or Not Reported
|
3 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
3 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Parent · American Indian or Alaska Native
|
0 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Parent · Asian
|
1 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Parent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Parent · Black or African American
|
8 Participants
n=55 Participants
|
2 Participants
n=25 Participants
|
10 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Parent · White
|
41 Participants
n=55 Participants
|
21 Participants
n=25 Participants
|
62 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Parent · More than one race
|
0 Participants
n=55 Participants
|
2 Participants
n=25 Participants
|
2 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Parent · Unknown or Not Reported
|
5 Participants
n=55 Participants
|
0 Participants
n=25 Participants
|
5 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=55 Participants
|
25 participants
n=25 Participants
|
80 participants
n=80 Participants
|
|
Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency
|
2.9 Checks per day
STANDARD_DEVIATION 1.8 • n=51 Participants • n represents number with complete data.
|
3.2 Checks per day
STANDARD_DEVIATION 1.4 • n=22 Participants • n represents number with complete data.
|
3.0 Checks per day
STANDARD_DEVIATION 1.7 • n=73 Participants • n represents number with complete data.
|
|
Glycemic control - HbA1c
|
9.1 percentage
STANDARD_DEVIATION 2.1 • n=55 Participants • n is the number with an HbA1c value available at this timepoint.
|
8.7 percentage
STANDARD_DEVIATION 2.1 • n=24 Participants • n is the number with an HbA1c value available at this timepoint.
|
9.0 percentage
STANDARD_DEVIATION 2.1 • n=79 Participants • n is the number with an HbA1c value available at this timepoint.
|
|
Ethnicity (NIH/OMB)
Adolescent · Not Hispanic or Latino
|
41 Participants
n=55 Participants
|
24 Participants
n=25 Participants
|
65 Participants
n=80 Participants
|
|
Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report
|
20.0 units on a scale
STANDARD_DEVIATION 12.9 • n=54 Participants • n represents number with complete data to calculate a score.
|
20.3 units on a scale
STANDARD_DEVIATION 17.7 • n=25 Participants • n represents number with complete data to calculate a score.
|
20.12 units on a scale
STANDARD_DEVIATION 14.5 • n=79 Participants • n represents number with complete data to calculate a score.
|
|
Family Impact - Pediatric Quality of Life Family Impact Module (Peds QL-FI), Parent-report
|
83.7 units on a scale
STANDARD_DEVIATION 13.6 • n=55 Participants
|
83.9 units on a scale
STANDARD_DEVIATION 13.2 • n=25 Participants
|
83.8 units on a scale
STANDARD_DEVIATION 13.4 • n=80 Participants
|
|
Family Communication - Helping for Health Inventory (HHI), Parent report
|
39.6 units on a scale
STANDARD_DEVIATION 11.0 • n=51 Participants • n represents number with complete data to calculate a score.
|
39.0 units on a scale
STANDARD_DEVIATION 9.2 • n=24 Participants • n represents number with complete data to calculate a score.
|
39.4 units on a scale
STANDARD_DEVIATION 10.4 • n=75 Participants • n represents number with complete data to calculate a score.
|
|
Family Communication - Helping for Health Inventory (HHI), Adolescent report
|
40.1 units on a scale
STANDARD_DEVIATION 11.6 • n=55 Participants • n represents number with complete data to calculate a score.
|
41.4 units on a scale
STANDARD_DEVIATION 12.0 • n=23 Participants • n represents number with complete data to calculate a score.
|
40.5 units on a scale
STANDARD_DEVIATION 11.7 • n=78 Participants • n represents number with complete data to calculate a score.
|
|
Diabetes Family Conflict Scale-Revised (DCFS), Parent-report
|
26.7 units on a scale
STANDARD_DEVIATION 6.1 • n=55 Participants
|
25.2 units on a scale
STANDARD_DEVIATION 3.5 • n=25 Participants
|
26.2 units on a scale
STANDARD_DEVIATION 5.5 • n=80 Participants
|
|
Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report
|
24.5 units on a scale
STANDARD_DEVIATION 4.7 • n=55 Participants
|
26.5 units on a scale
STANDARD_DEVIATION 8.4 • n=25 Participants
|
25.1 units on a scale
STANDARD_DEVIATION 6.1 • n=80 Participants
|
|
Problem Areas in Diabetes-Teen (PAID-T), Parent-report
|
73.9 units on a scale
STANDARD_DEVIATION 21.9 • n=55 Participants
|
68.4 units on a scale
STANDARD_DEVIATION 18.9 • n=25 Participants
|
72.2 units on a scale
STANDARD_DEVIATION 21.0 • n=80 Participants
|
|
Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report
|
63.5 units on a scale
STANDARD_DEVIATION 25.8 • n=55 Participants
|
63.5 units on a scale
STANDARD_DEVIATION 29.8 • n=25 Participants
|
63.5 units on a scale
STANDARD_DEVIATION 26.9 • n=80 Participants
|
|
Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report
|
52.1 units on a scale
STANDARD_DEVIATION 12.8 • n=55 Participants
|
52.3 units on a scale
STANDARD_DEVIATION 10.5 • n=25 Participants
|
52.1 units on a scale
STANDARD_DEVIATION 12.1 • n=80 Participants
|
|
Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report
|
69.1 units on a scale
STANDARD_DEVIATION 13.2 • n=55 Participants
|
66.3 units on a scale
STANDARD_DEVIATION 15.1 • n=25 Participants
|
68.2 units on a scale
STANDARD_DEVIATION 13.8 • n=80 Participants
|
|
Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report
|
37.6 units on a scale
STANDARD_DEVIATION 6.3 • n=53 Participants • n represents number with complete data to calculate a score.
|
34.8 units on a scale
STANDARD_DEVIATION 5.3 • n=25 Participants • n represents number with complete data to calculate a score.
|
36.7 units on a scale
STANDARD_DEVIATION 6.1 • n=78 Participants • n represents number with complete data to calculate a score.
|
|
Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent self-report
|
72.3 units on a scale
STANDARD_DEVIATION 12.9 • n=54 Participants • n represents number with complete data to calculate a score.
|
70.7 units on a scale
STANDARD_DEVIATION 15.1 • n=25 Participants • n represents number with complete data to calculate a score.
|
71.8 units on a scale
STANDARD_DEVIATION 13.5 • n=79 Participants • n represents number with complete data to calculate a score.
|
PRIMARY outcome
Timeframe: Immediately following enrollment (baseline timepoint)Population: Out of 108 families successfully contacted and confirmed eligible, 8 families declined due to time demands, 6 were disinterested in research, and 2 felt the study was not relevant for their child's age. 8 families were unable to be contacted for a decision after giving study information. 84 families consented (78% consent rate).
Recruitment data measured by percent of recruited families that enrolled in study.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=108 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
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.
T1Doing Well: 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.
|
|---|---|---|
|
Feasibility of Study Design - Recruitment Rate
|
84 Participants
|
—
|
PRIMARY outcome
Timeframe: 3-4 months after enrollment (follow-up timepoint)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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=55 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
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.
T1Doing Well: 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.
|
|---|---|---|
|
Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week
|
50 Participants
|
—
|
PRIMARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=55 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
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.
T1Doing Well: 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.
|
|---|---|---|
|
Acceptability of T1Doing Well App (Survey)
|
48 Participants
|
—
|
PRIMARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number we were able to reach and obtain follow-up interview data
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=46 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=47 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Acceptability - Number of Participants That Felt The Intervention Was Well-Received
|
35 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=33 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=18 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency
|
2.6 Checks per day
Standard Deviation 1.9
|
3.1 Checks per day
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n is the number with an HbA1c value available at this timepoint.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=51 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=22 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Glycemic Control - HbA1c
|
8.7 percentage
Standard Deviation 1.7
|
8.4 percentage
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=54 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report
|
20.7 units on a scale
Standard Deviation 15.5
|
19.1 units on a scale
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=54 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report
|
82.6 units on a scale
Standard Deviation 14.1
|
84.5 units on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=52 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Family Communication - Helping for Health Inventory (HHI), Parent-report
|
40.0 units on a scale
Standard Deviation 12.5
|
40.0 units on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=51 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=23 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Family Communication - Helping for Health Inventory (HHI), Adolescent-report
|
37.9 units on a scale
Standard Deviation 10.6
|
41.4 units on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=54 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Diabetes Family Conflict Scale-Revised (DFCS), Parent-report
|
25.4 units on a scale
Standard Deviation 5.2
|
24.5 units on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=54 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report
|
23.9 units on a scale
Standard Deviation 4.5
|
25.0 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=55 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Problem Areas in Diabetes-Teen (PAID-T), Parent-report
|
77.6 units on a scale
Standard Deviation 28.1
|
71.0 units on a scale
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=53 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report
|
65.0 units on a scale
Standard Deviation 26.1
|
65.2 units on a scale
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=54 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report
|
53.4 units on a scale
Standard Deviation 10.8
|
53.0 units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=54 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=25 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report
|
66.6 units on a scale
Standard Deviation 14.0
|
68.4 units on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=52 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=25 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report
|
37.7 units on a scale
Standard Deviation 5.7
|
35.1 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)Population: n represents number with complete data to calculate a score.
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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=53 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=24 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent Self-report
|
72.2 units on a scale
Standard Deviation 11.8
|
68.4 units on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 3-4 months after baseline (follow-up timepoint)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.
Outcome measures
| Measure |
Adolescent-Parent Dyads
n=55 Participants
Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.
Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app.
|
Intervention - Adolescent
n=25 Participants
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.
T1Doing Well: 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.
|
|---|---|---|
|
Parent-Adolescent Relationship Intervention Process Measure, Adolescent Report
|
.0012 scores per day
Interval -0.0013 to 0.0037
|
.0045 scores per day
Interval 0.0007 to 0.0083
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marisa Hilliard, Associate Professor of Pediatrics
Baylor College of Medicine
Phone: 832-824-7209
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place