Diabetes Mellitus, Type 2
Conditions
Keywords
CBT, Type 2 Diabetes, Diabetes Distress, Adherence, Smartphone App, Self-management
Brief summary
This is a pilot study examining the clinical effects of a brief Cognitive Therapy phone approach augmented with a CBT smartphone app geared towards patients with type 2 diabetes patients in poor control.
Detailed description
A significant problem in primary care healthcare delivery is the lack of interventions to improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM). Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications, and self-management burdens is present in up to 70% of persons with T2DM. Distress is a significant factor in medication nonadherence and poor glycemic control. Treatment adherence is vital to maintain glucose control and reduce complications. The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't handle taking these medications), assumptions (e.g., I know I will have side effects to these medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff) as critical variables that impact both distress and T2DM treatment adherence. Current treatment strategies within primary care do not address the dysfunctional thinking patterns that affect the patient's distress level, T2DM medication adherence, and complex daily self-care activities. Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps patients to identify, and restructure dysfunctional thinking patterns. The investigators propose to test a brief phone CBT approach that is supported by a comprehensive mobile phone CBT skills practice application (app) within primary care. The promising results of the investigators preliminary studies using a mobile phone app to stimulate real-time CBT skills practice prompt us to propose a pilot of its use with patients with T2DM with the following aims: Primary aim: examine feasibility and acceptability of the assessment protocol, and the recruitment, and retention of study participants. Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g., diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM outcomes (HbA1c level and body mass index).
Interventions
BEHAVIORALCBT
Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
DEVICESmartphone app
Smartphone app developed to assist patients practice CBT skills throughout the week
OTHERStandard Diabetes Care at PCP
Patients receive ADA standard of Care with physician at PCP office
Sponsors
National Institutes of Health (NIH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. have a diagnosis of T2DM; 2. have a score of \>3 on the Diabetes Distress Scale; 3. be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic medications, including insulin); 4. have an HbA1c level of greater than 8 at baseline; 5. be receiving treatment for T2DM in the primary care setting; 6. be aged 30 - 65 years and 7. be able to read at the 8th-grade level and to provide informed consent. -
Exclusion criteria
1. diagnosis of bipolar disorder or schizophrenia; primary diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, substance abuse, or dependence in the last 6 months; or any psychotic disorder; 2. diabetes treated without oral medications; 3. inability to read or comprehend English at the 8th-grade level; 4. refusal to provide informed consent; 5. dementia or disorders with substantial cognitive impairment; and 6. serious suicidal risk -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Level Change Scores From Baseline to 16 Weeks | baseline to 16 weeks | Change from baseline HbA1c level to post intervention |
| Computer System Usability Questionnaire (CSUQ) | 16 weeks | The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence | 16 weeks | Electronically measured medication adherence, percent adherence over entire study phase. Change score was not evaluated, this measure is to determine feasability of use over time. Percent adherence is measured by the number of correct doses per day divided by the number of prescribed doses per day X 100. Percent adherence was calculated as the percentage of the prescribed doses of the medication actually taken by the patient over 16 weeks |
| Diabetes Distress Scale- Change Score | baseline to 16 weeks | Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Percent change of mean score between baseline and 16 weeks is reported. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252. |
| Body Mass Index Change | baseline to 16 weeks | Change in Body Mass Index from baseline to post intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 Weeks Phone CBT Plus Smartphone App Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office | 3 |
| 8 Weeks Phone CBT Plus Smartphone App Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office | 3 |
| 12 Weeks Phone CBT Plus Smartphone App Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office | 4 |
| Treatment as Usual Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office | 3 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Head injury not related to study | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | 6 Weeks Phone CBT Plus Smartphone App | 12 Weeks Phone CBT Plus Smartphone App | Treatment as Usual | 8 Weeks Phone CBT Plus Smartphone App | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 1 | 59.50 years STANDARD_DEVIATION 3.42 | 60.67 years STANDARD_DEVIATION 0.58 | 50.67 years STANDARD_DEVIATION 12.34 | 57.38 years STANDARD_DEVIATION 6.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Region of Enrollment United States | 3 participants | 4 participants | 3 participants | 3 participants | 13 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 | 1 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 3 |
Outcome results
Primary
Computer System Usability Questionnaire (CSUQ)
The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability.
Time frame: 16 weeks
Population: As per protocol, usability was analyzed for participants administered phone CBT, regardless of duration. Six subjects completed the CSUQ. Of ten initially assigned treatment, one was withdrawn prior to treatment, one missed the CSUQ, and two dropped out. Treatment as usual Arm did not use the phone.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Administered Phone CBT | Computer System Usability Questionnaire (CSUQ) | 3.0 units on a scale (1-7) | Standard Deviation 2.1 |
Primary
HbA1c Level Change Scores From Baseline to 16 Weeks
Change from baseline HbA1c level to post intervention
Time frame: baseline to 16 weeks
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Weeks Phone CBT Plus Smartphone App | HbA1c Level Change Scores From Baseline to 16 Weeks | -0.60 percent | Standard Deviation 0.26 |
| 8 Weeks Phone CBT Plus Smartphone App | HbA1c Level Change Scores From Baseline to 16 Weeks | -2.30 percent | Standard Deviation 0 |
| 12 Weeks Phone CBT Plus Smartphone App | HbA1c Level Change Scores From Baseline to 16 Weeks | -2.33 percent | Standard Deviation 0.5 |
| Treatment as Usual | HbA1c Level Change Scores From Baseline to 16 Weeks | -2.15 percent | Standard Deviation 1.63 |
Secondary
Body Mass Index Change
Change in Body Mass Index from baseline to post intervention
Time frame: baseline to 16 weeks
Population: Of 13 initially randomized, there were 2 dropouts and one was withdrawn from the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 6 Weeks Phone CBT Plus Smartphone App | Body Mass Index Change | .23 kg/m^2 |
| 8 Weeks Phone CBT Plus Smartphone App | Body Mass Index Change | -1.2 kg/m^2 |
| 12 Weeks Phone CBT Plus Smartphone App | Body Mass Index Change | .53 kg/m^2 |
| Treatment as Usual | Body Mass Index Change | .35 kg/m^2 |
Secondary
Diabetes Distress Scale- Change Score
Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Percent change of mean score between baseline and 16 weeks is reported. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.
Time frame: baseline to 16 weeks
Population: Of thirteen initially randomized, one was withdrawn prior to treatment, one is missing data, and two dropped out. Therefore we do not have change scores for these pariticipants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 6 Weeks Phone CBT Plus Smartphone App | Diabetes Distress Scale- Change Score | -17.98 percent change |
| 8 Weeks Phone CBT Plus Smartphone App | Diabetes Distress Scale- Change Score | -8.33 percent change |
| 12 Weeks Phone CBT Plus Smartphone App | Diabetes Distress Scale- Change Score | -40.92 percent change |
| Treatment as Usual | Diabetes Distress Scale- Change Score | -36.22 percent change |
Secondary
MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence
Electronically measured medication adherence, percent adherence over entire study phase. Change score was not evaluated, this measure is to determine feasability of use over time. Percent adherence is measured by the number of correct doses per day divided by the number of prescribed doses per day X 100. Percent adherence was calculated as the percentage of the prescribed doses of the medication actually taken by the patient over 16 weeks
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 6 Weeks Phone CBT Plus Smartphone App | MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence | 37.7 percent adherent |
| 8 Weeks Phone CBT Plus Smartphone App | MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence | 35.7 percent adherent |
| 12 Weeks Phone CBT Plus Smartphone App | MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence | 88.69 percent adherent |
| Treatment as Usual | MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence | 84.06 percent adherent |