Type 1 Diabetes Mellitus
Conditions
Brief summary
Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes. Participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records.
Interventions
BEHAVIORALPositive Affect
Positive psychology intervention to improve motivation for diabetes management.
BEHAVIORALEducation
Educational materials on diabetes management
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were assigned to Positive Affect - Phone, Positive Affect - Text, or Education groups for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 1 diabetes for at least 6 months * HbA1c between 8-12% * Speak and read English * Caregiver living with child
Exclusion criteria
* Other uncontrolled health conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (HbA1c) | 6 months | HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \<7.5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Blood Glucose Monitoring | 6 months | Glucometer download to determine blood glucose checks per day. |
| Diabetes-Related Quality of Life | 6 months | The 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. |
| Family Conflict | 6 months | Diabetes-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. |
| Positive Affect | 6 months | Positive 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. |
| Coping | 6 months | Responses 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Education Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Education: Educational materials on diabetes management | 60 |
| 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 | 29 |
| 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 | 29 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Education | Positive Affect - Text | Positive Affect - Phone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 60 Participants | 29 Participants | 29 Participants | 118 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.92 years STANDARD_DEVIATION 1.42 | 14.62 years STANDARD_DEVIATION 1.63 | 14.97 years STANDARD_DEVIATION 1.4 | 14.86 years STANDARD_DEVIATION 1.46 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Biracial/Multiracial | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African american | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White Hispanic | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White-Non Hispanic | 53 Participants | 26 Participants | 25 Participants | 104 Participants |
| Region of Enrollment United States | 60 participants | 29 participants | 29 participants | 118 participants |
| Sex: Female, Male Female | 35 Participants | 12 Participants | 15 Participants | 62 Participants |
| Sex: Female, Male Male | 25 Participants | 17 Participants | 14 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 60 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Glycemic Control (HbA1c)
HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \<7.5%.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Glycemic Control (HbA1c) | 8.8 percentage of glycated hemoglobin |
| Positive Affect - Text | Glycemic Control (HbA1c) | 9 percentage of glycated hemoglobin |
| Positive Affect - Phone | Glycemic Control (HbA1c) | 8.5 percentage of glycated hemoglobin |
Secondary
Coping
Responses 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.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Coping | 107 score on a scale |
| Positive Affect - Text | Coping | 99 score on a scale |
| Positive Affect - Phone | Coping | 104 score on a scale |
Secondary
Diabetes-Related Quality of Life
The 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.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Diabetes-Related Quality of Life | 72 score on a scale |
| Positive Affect - Text | Diabetes-Related Quality of Life | 79 score on a scale |
| Positive Affect - Phone | Diabetes-Related Quality of Life | 73 score on a scale |
Secondary
Family Conflict
Diabetes-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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Education | Family Conflict | Child reported | 23.5 score on a scale |
| Education | Family Conflict | Parent reported | 23 score on a scale |
| Positive Affect - Text | Family Conflict | Parent reported | 25 score on a scale |
| Positive Affect - Text | Family Conflict | Child reported | 27 score on a scale |
| Positive Affect - Phone | Family Conflict | Parent reported | 25 score on a scale |
| Positive Affect - Phone | Family Conflict | Child reported | 36 score on a scale |
Secondary
Frequency of Blood Glucose Monitoring
Glucometer download to determine blood glucose checks per day.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Frequency of Blood Glucose Monitoring | 3.1 blood glucose checks per day |
| Positive Affect - Text | Frequency of Blood Glucose Monitoring | 3.46 blood glucose checks per day |
| Positive Affect - Phone | Frequency of Blood Glucose Monitoring | 2.8 blood glucose checks per day |
Secondary
Positive Affect
Positive 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.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Positive Affect | 35 score on a scale |
| Positive Affect - Text | Positive Affect | 37 score on a scale |
| Positive Affect - Phone | Positive Affect | 41 score on a scale |