Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Primary Health Care, Self care
Brief summary
This project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes.
Detailed description
The specific aims of the proposed study are: * Primary Specific Aims 1. To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for patients with type 2 diabetes in primary care practice settings. Primary effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood pressure and Low Desity Lipprotein (LDL) cholesterol. 2. To determine the incremental benefit, using the RE-AIM framework, of brief targeted practice coaching on the implementation of CTH in diverse primary care practices. * Secondary Specific Aims 1. To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact CTH RE-AIM. These results will inform dissemination of the CTH intervention. 2. To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.
Interventions
BEHAVIORALSelf-management support education
Same as Arm Description
BEHAVIORALConnection to Health Interactive Behavior Change Technology
Same as Arm Description
BEHAVIORALConnection to Health plus Coaching (CTH+C)
Same as Arm Description
Sponsors
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age 21 years old or over * Type 2 Diabetes Mellitus diagnosed for a minimum of 12 months * Able to read in English or Spanish * Plan to remain in the practice during the study period
Exclusion criteria
* Developmentally disabled * Decisionally challenged * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from baseline to 18 months | 18 months from baseline | Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline. |
| Change in LDL from baseline to 18 months | 18 months from baseline | Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL). |
| Change in systolic and diastolic blood pressure from baseline to 18 months | 18 months from baseline | Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg) |
| Change in body mass index (BMI) from baseline to 18 months | 18 months from baseline | Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / \[height (m)\]2; e.g., 24.96) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of documented self-management support for patients through medical record review | 18 months from baseline | The following elements will be assessed in medical record review: presence of a personal care plan with regular updating, evidence of collaborative goal setting, evidence of action planning around prioritized patient goals, evidence of collaborative problem-solving regarding the action planning process, use of community resources to assist in goal attainment, and evidence of ongoing monitoring of progress on identified goals. A total score will be the sum of positive elements. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages baseline to 18 months | 18 months from baseline | Patients' dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages will be assessed at baseline and 18 months from baseline through a patient-completed survey on their diet. |
| Change in patient-reported diabetes self-care rating from baseline to 18 months | 18 months from baseline | Patients' measure of the frequency of performing diabetes self-care tasks over the preceding 7 days will be assessed at baseline and 18 months from baseline through a patient-completed survey. |
| Change in patient-reported physical activity from baseline to 18 months | 18 months from baseline | Patients' frequency and duration of participation in vigorous, moderate, and walking activity as well as screen time and time spent sitting will be assessed at baseline and 18 months from baseline through a patient-completed survey on their physical activity. |
| Change in patient-reported tobacco use from baseline to 18 months | 18 months from baseline | Patients' use of tobacco (whether or not using tobacco, if so, how much; e.g., current smoker \[yes/no\]; number of cigarettes \[10 in the past week\]) will be assessed at baseline and 18 months from baseline through a patient-completed survey. |
| Change in patient-reported medication adherence from baseline to 18 months | 18 months from baseline | Patients' prescribed medication adherence (number of days missed, reasons for missing) will be assessed at baseline and 18 months from baseline through a patient-completed survey. |
| Change in patient-reported disease-related distress rating from baseline to 18 months | 18 months from baseline | Patients' distress related to their diabetes (6-point scales for each item; mean score calculated for each sub-scale \[range between 1 and 6\]) will be assessed at baseline and 18 months from baseline through a patient-completed survey. |
Countries
United States
Outcome results
None listed