AMGA and Pfizer Inc. present the Models of Excellence Collaborative on Patient Adherence and Health Literacy

Ochsner Clinic Foundation, New Orleans, LA
Improving Adherence to Physical Activity in Patients with Diabetes Mellitus

Download a copy of the Final Report

EXECUTIVE SUMMARY: Diabetes Mellitus is a prevalent chronic condition that is increasing at epidemic proportions. Nearly 17 million Americans presently have diabetes and there are almost a million new cases diagnosed annually. Diabetes is associated with extremely high morbidity, mortality, and costs. In 2002, the United States spent 132 billion dollars in the care of people with diabetes. Important benefits of regular physical activity in diabetic patients have been reported including improved glycemic control and improved physical functioning. However, adherence to recommendations for diabetic patients’ participation in regular physical activity is generally poor. Some barriers to patient adherence include: cost, time, climate and location. The proposed study will develop and evaluate a low-cost, high quality, home-based exercise education intervention that will be incorporated into an existing diabetes self management education program, and assess whether it will enhance patient adherence to recommendations for regular physical activity. To our knowledge, there have not been studies of the efficacy of coupling a home-based exercise education program with a diabetes self management education program. A portable, low-cost exercise education intervention that could easily be integrated into clinical practice would have widespread application in diverse clinical settings for people with diabetes and perhaps other conditions.

The primary hypothesis is patients with diabetes who are randomized to the home-based exercise educational video intervention will report increased adherence to a recommendation for regular physical activity when compared to controls. Specific aims or objectives follow:

• Develop the home-based exercise education intervention (i.e. videotape)
• Conduct a randomized controlled trial of patients with diabetes enrolled in the Diabetes Self Management Program.
• Collect data from intervention and control patients (using valid and reliable instruments) at baseline and at one month intervals for 3 months on the primary outcome variable, physical activity adherence, and secondary endpoints (i.e. glycemic control, physical functioning, body mass index, medication adherence, blood pressure control and patient satisfaction).
• Compare physical activity adherence and secondary endpoints between intervention and control groups using appropriate statistical techniques.
• Summarize study findings and submit for presentation and publication.
• Prepare deliverables for study: budget, working processes, timeline for implementation, summary of lessons learned, and study design.

This study proposes to develop and evaluate an intervention that targets improving patient adherence through systematic approaches in an effort to improve patient outcomes.

PROJECT PLAN:
Step 1: The PI and co-investigator, in conjunction with a nationally-recognized fitness expert, will develop and reproduce a low-cost, high quality videotape which includes home-based exercise instruction and demonstrations that correspond to the Diabetes Self-Management Program instruction and national recommendations for physical activity

Step 2: The Research Program Manager, in conjunction with the Diabetes Institute personnel, will approach patients who are referred to the first class of the Diabetes Institute Self Management Program and determine eligibility for and willingness to participate in the study. Eligibility criteria include: English-speaking adult (age 18-69) men and women with type 2 diabetes who, at baseline, do not engage in regular physical activity (30 minutes or more of moderate physical activity 5 or more days per week), are not currently enrolled in another clinical trial, and are without significant disabilities or comorbid conditions which would limit their ability to engage in physical activity.

Step 3: The Research Program Manager will ensure that patients deemed eligible and willing to participate in the study will sign written informed consent and HIPAA authorization documents.

Step 4: Patients completing step 3 will be randomized (using a random number algorithm generated by the statistician) by the Research Program Manager to either the intervention (n= 50 patients) or the control group (n=50 patients). Each participant will be given a pedometer. Pedometers and activity logs will be distributed along with instructions to intervention and control groups.

Step 5: At baseline assessment (one week post-enrollment), the Research Program Manager will see each patient to review and collect the baseline pedometer readings and activity logs. Measurements of physical activity (IPAQ), physical functioning (PF-10), medication adherence (Morisky scale), blood pressure, glycemic control (A1C), and satisfaction (modified GHAA) will be determined. Patients randomized to the intervention group will receive the Exercise videotape.

Step 6: Thereafter, intervention and control patients will be seen by the Research Program Manager at 1 month intervals up to 3 months post baseline assessment. The following measurements will be obtained at each follow-up: physical activity (IPAQ, pedometer readings and activity logs), medication adherence (Morisky scale), blood pressure, BMI, and satisfaction (modified GHAA). At month 3, follow-up glycemic control (A1C) and physical functioning (PF10) will be assessed.

Step 7: Data collected at designated time intervals will be entered into a study-specific, password protected database, and interim and final analyses performed.

Step 8: Based on the final analyses, a report of the findings will be written and ultimately submitted for publication and presentation.

Study Progress will be assessed at biweekly meetings of the project team (PI, co-I, Research PM, statistician). The Research PM will maintain databases of patient enrollment, completion of baseline and follow-up assessments, patient reported barriers. The database information will be reviewed and discussed at the biweekly meetings. Potential Barriers to Progress will include difficulty recruiting/enrolling patients, patient-perceived barriers with the exercise video, poor patient compliance with completion of activity logs and surveys, and low satisfaction with the exercise video. Information regarding barriers will be solicited from the Research PM regarding patient recruitment and enrollment. Patients will be asked to mail in the physical activity and pedometer logs at the end of each week; an open-ended question regarding barriers to physical activity will be included. Patients not returning the logs within 2 weeks will receive a reminder call or letter from the PI or Co-Investigator. Interim analyses of the data will provide evidence of completion of data collection tools; reinforcement of importance of completion will be done at follow-up visits.

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