Trial Outcomes & Findings for Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D (NCT NCT02746627)
NCT ID: NCT02746627
Last Updated: 2019-03-13
Results Overview
HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \<7.5%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
6 months
Results posted on
2019-03-13
Participant Flow
Participant milestones
| Measure |
Education
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
30
|
|
Overall Study
COMPLETED
|
59
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Education
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
Baseline Characteristics
Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D
Baseline characteristics by cohort
| Measure |
Education
n=60 Participants
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
n=29 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
n=29 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Biracial/Multiracial
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
29 participants
n=107 Participants
|
29 participants
n=206 Participants
|
118 participants
n=7 Participants
|
|
Age, Categorical
<=18 years
|
60 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
14.92 years
STANDARD_DEVIATION 1.42 • n=99 Participants
|
14.62 years
STANDARD_DEVIATION 1.63 • n=107 Participants
|
14.97 years
STANDARD_DEVIATION 1.40 • n=206 Participants
|
14.86 years
STANDARD_DEVIATION 1.46 • n=7 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White-Non Hispanic
|
53 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
104 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African american
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsHbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \<7.5%.
Outcome measures
| Measure |
Education
n=59 Participants
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
n=29 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
n=29 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Glycemic Control (HbA1c)
|
8.8 percentage of glycated hemoglobin
Interval 8.0 to 9.7
|
9 percentage of glycated hemoglobin
Interval 8.3 to 9.8
|
8.5 percentage of glycated hemoglobin
Interval 8.0 to 9.0
|
SECONDARY outcome
Timeframe: 6 monthsGlucometer download to determine blood glucose checks per day.
Outcome measures
| Measure |
Education
n=49 Participants
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
n=25 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
n=24 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Frequency of Blood Glucose Monitoring
|
3.1 blood glucose checks per day
Interval 2.1 to 3.7
|
3.46 blood glucose checks per day
Interval 2.6 to 4.0
|
2.8 blood glucose checks per day
Interval 1.9 to 3.51
|
SECONDARY outcome
Timeframe: 6 monthsThe Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life. Scaled scores range from 0-100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Education
n=55 Participants
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
n=25 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
n=25 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Diabetes-Related Quality of Life
|
72 score on a scale
Interval 62.5 to 82.0
|
79 score on a scale
Interval 72.0 to 82.0
|
73 score on a scale
Interval 68.0 to 83.0
|
SECONDARY outcome
Timeframe: 6 monthsDiabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater conflict.
Outcome measures
| Measure |
Education
n=54 Participants
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
n=25 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
n=25 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Family Conflict
Parent reported
|
23 score on a scale
Interval 22.0 to 35.0
|
25 score on a scale
Interval 20.0 to 29.0
|
25 score on a scale
Interval 21.0 to 28.0
|
|
Family Conflict
Child reported
|
23.5 score on a scale
Interval 20.0 to 36.0
|
27 score on a scale
Interval 19.0 to 44.0
|
36 score on a scale
Interval 21.0 to 45.0
|
SECONDARY outcome
Timeframe: 6 monthsPositive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items. Scores range from 15-75, and higher scores indicate higher levels of positive affect.
Outcome measures
| Measure |
Education
n=59 Participants
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
n=29 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
n=29 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Positive Affect
|
35 score on a scale
Interval 27.5 to 42.5
|
37 score on a scale
Interval 28.0 to 42.0
|
41 score on a scale
Interval 32.0 to 46.0
|
SECONDARY outcome
Timeframe: 6 monthsResponses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress. Scores range from 57-228, and higher scores indicate more responses to stress.
Outcome measures
| Measure |
Education
n=55 Participants
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management
|
Positive Affect - Text
n=25 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
Positive Affect - Phone
n=25 Participants
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
|
|---|---|---|---|
|
Coping
|
107 score on a scale
Interval 91.0 to 125.0
|
99 score on a scale
Interval 87.0 to 126.0
|
104 score on a scale
Interval 92.0 to 121.0
|
Adverse Events
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Affect - Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Affect - Phone
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place