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| ID | Type | Description | Link |
|---|---|---|---|
| School of Nursing eHub pilot | Other Identifier | University of Pittsburgh School of Nursing |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief CBT | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief CBT | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Diabetes Distress Scale |
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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:
Four nurse care managers will also be recruited from UPMC Health Care. To be considered they must be employed at UPMC Health Care and
Nurses will be excluded from the study if:
Exclusion Criteria:
The following are exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A. Callan, PhD, RN | University of Pittsburgh School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh School of Nursing | Pittsburgh | Pennsylvania | 15261 | United States |
This is a small sample feasibility study.
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Screened to have mean distress over 2.0 and HbA1C of 8 or above via measurements by our tests.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Mean acceptability of the Brief CBT protocol. | Posted | Mean | Standard Deviation | mean of scale items | 12 weeks |
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during the participant's participation in the study, 12-16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This is a pilot feasibility study with small sample (N=10)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith A. Callan | University of Pittsburgh School of Nursing | 412-383-5321 | callanja@pitt.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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. |
| 12 weeks |
| 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. | 12 weeks |
| HbA1c Level | Change in HbA1c from before to after treatment | 12 weeks |
| Body Mass Index | Change in Body Mass Index from before to after treatment | 12 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| HbA1C | Mean | Standard Deviation | percent |
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| Distress (Diabetes Distress Scale) | The Brief Diabetes Distress Scale is a 17 item scale assessing distress in managing diabetes. The scale is scored as an average with a potential range from 1 to 6. Scores of 3 or greater are considered indicating stress. Fisher, L., Glasgow, R. E., Mullan, J. T., Skaff, M. M., & Polonsky, W. H. (2008). Development of a brief diabetes distress screening instrument. The Annals of Family Medicine, 6(3), 246-252. | Mean | Standard Deviation | mean result on scale |
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| 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. | Mean change from baseline to 12 weeks. | Posted | Mean | Standard Deviation | mean of scale items | 12 weeks |
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| 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. | Change in score from baseline to post followup | Posted | Mean | Standard Deviation | mean of scale items | 12 weeks |
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| 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. | Posted | 12 weeks |
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| Secondary | HbA1c Level | Change in HbA1c from before to after treatment | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | 12 weeks |
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| Secondary | Body Mass Index | Change in Body Mass Index from before to after treatment | Change BMI over time. | Posted | Mean | Standard Deviation | kg/m^2 | 12 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
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| D004700 | Endocrine System Diseases |