Diabetes Mellitus, Type 2
Conditions
Keywords
Brief CBT, smartphone app, mHealth, diabetes distress, adherence, cognitive behavioral therapy
Brief summary
Primary aim: examine feasibility and acceptability of a brief cognitive therapy protocol for type II diabetes administered by nurse care managers or health coaches via phone.
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. We propose to test a brief CBT approach delivered by nurse care managers and supported by a comprehensive mobile phone CBT skills practice application (app) within primary care. The promising results of our 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
BEHAVIORALBrief CBT
During the course of the twice/month diabetes management phone sessions the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT intervention that will be most appropriate for the situation. Each intervention is described step by step in the app. The nurse will go through the intervention and when completed will assure the patient's understanding.CBT interventions are geared towards helping the patient identify and restructure thinking that is impairing successful self-management of a chronic disease
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Ten adults will be recruited through the UPMC health plan and are treated at a primary care center. To be considered for inclusion subjects must: 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. Four nurse care managers will also be recruited from UPMC Health Care. To be considered they must be employed at UPMC Health Care and 1. Have received the Brief CBT Training that was given in Phase I of this study; 2. Be identified as a RN or a RN who is a diabetes nurse educator; and have Nurse Care Management responsibilities with patients who have Type 2 Diabetes. Nurses will be excluded from the study if: 1. They did not successfully complete the training in Phase I or 2. Are not Nurse Care Managers at UPMC Health Care. -
Exclusion criteria
The following are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Questionnaire. | 12 weeks | The acceptability questionnaire measures feasibility and acceptability of the Brief CBT protocol. 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 and ranges from 1-7. In this adaptation, lower scores are better satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morisky Questionnaire | 12 weeks | Brief scale of adherence to medications. Morisky 5 items was used. Mean score presented. Scale range is from 5-13. Lower score is better adherence. Mean change from baseline to 12 weeks is examined. |
| Diabetes Distress Scale | 12 weeks | Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Change of mean score is reported. Change in score from baseline to post followup. Lower score means less distress. Scale range is from 1-6. 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. |
| Medication Beliefs Scale | 12 weeks | Change in medication beliefs from before and after intervention. Adapted from Horne, R., Weinman, J., Hankins, M. (1999). The Beliefs About Medicines Questionnaire: The Development and Evaluation of a New Method for Assessing the Cognitive Representation of Medications. Psychology and Health 14: 1-24. |
| HbA1c Level | 12 weeks | Change in HbA1c from before to after treatment |
| Body Mass Index | 12 weeks | Change in Body Mass Index from before to after treatment |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a existing cases of nurse care managers and health coaches who administered the study intervention. Individuals who were interested and had HbA1C higher than 8.0 were screened.
Pre-assignment details
Screened to have mean distress over 2.0 and HbA1C of 8 or above via measurements by our tests.
Participants by arm
| Arm | Count |
|---|---|
| Brief CBT During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Brief CBT |
|---|---|
| Age, Continuous | 47.7 years |
| Distress (Diabetes Distress Scale) | 3.52 mean result on scale STANDARD_DEVIATION 1.47 |
| HbA1C | 9.8 percent STANDARD_DEVIATION 0.9 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Acceptability Questionnaire.
The acceptability questionnaire measures feasibility and acceptability of the Brief CBT protocol. 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 and ranges from 1-7. In this adaptation, lower scores are better satisfaction.
Time frame: 12 weeks
Population: Mean acceptability of the Brief CBT protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief CBT | Acceptability Questionnaire. | 2.49 mean of scale items | Standard Deviation 1.39 |
Secondary
Body Mass Index
Change in Body Mass Index from before to after treatment
Time frame: 12 weeks
Population: Change BMI over time.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief CBT | Body Mass Index | -1.22 kg/m^2 | Standard Deviation 1.39 |
Secondary
Diabetes Distress Scale
Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Change of mean score is reported. Change in score from baseline to post followup. Lower score means less distress. Scale range is from 1-6. 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: 12 weeks
Population: Change in score from baseline to post followup
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief CBT | Diabetes Distress Scale | -.77 mean of scale items | Standard Deviation 1.35 |
Secondary
HbA1c Level
Change in HbA1c from before to after treatment
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief CBT | HbA1c Level | -.22 percentage of glycosylated hemoglobin | Standard Deviation 1.8 |
Secondary
Medication Beliefs Scale
Change in medication beliefs from before and after intervention. Adapted from Horne, R., Weinman, J., Hankins, M. (1999). The Beliefs About Medicines Questionnaire: The Development and Evaluation of a New Method for Assessing the Cognitive Representation of Medications. Psychology and Health 14: 1-24.
Time frame: 12 weeks
Secondary
Morisky Questionnaire
Brief scale of adherence to medications. Morisky 5 items was used. Mean score presented. Scale range is from 5-13. Lower score is better adherence. Mean change from baseline to 12 weeks is examined.
Time frame: 12 weeks
Population: Mean change from baseline to 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief CBT | Morisky Questionnaire | .10 mean of scale items | Standard Deviation 1.73 |