Diabetes Mellitus Clinical Trial
Official title:
A Randomized Controlled Trial Linking Clinical Quality Improvement Programs for Older Diabetics to a Community Based Activity Support Center
This is a study of whether physical activity of older adults can be improved by linking
primary care clinics serving older adults to a community-based program that provides
motivational support, including peer counselors, for engaging in and maintaining moderate
levels of physical activity.
Health care providers at the participating study sites routinely assess and track diabetic
patients' physical activity. In addition to this routine care, study volunteers are referred
to a support program that has been modelled on the Active Choices Program. Changes in
volunteers' levels of activity are measured at 3, 6, and 12 months.
The MY PALS project will focus on developing an organized approach to increasing physical
activity for clients who have already decided they are willing to increase activity or who
might be having difficulty maintaining activity.
The MY PALS study will enroll consenting patients at clinics in Southeast Seattle-initially
at two Puget Sound Neighborhood Health Center community clinics. These clinics have existing
programs to provide better care for diabetic patients by encouraging and tracking physical
activity, but the existing programs do not include community-based motivational supports.
Goals and objectives: The primary aim of My PALS is to determine the effectiveness of a
support program to improve levels of physical activity in older diabetic patients in a
diverse group of patients of clinics in SE Seattle. Secondary aims include: 1) identifying
barriers to increased physical activity despite the offer or use of enhanced supports, and
examining what those barriers imply for future study; and 2) estimating non-costs of the
intervention.
The program consists of phone support, in-person counseling if the volunteer chooses, and
access to a mentor if the volunteer chooses.
At initial contact, participants will complete a baseline questionnaire, including a the
Seattle Rapid Assessment of Physical Activity (Seattle-RAPA). Participants desiring to meet
in person with a peer counselor will discuss further plans for action and followup. In
addition, participants who desire extra support will be offered the option of an ongoing
peer mentor.
Participants will receive follow-up calls at the agreed upon intervals—usually no more than
weekly, nor less than monthly for the first 3 months. At 3, 6 and 12 months, volunteers will
again be asked to complete followup questionnaires. Copies of the plans and follow up
activity scores will be sent to the volunteers' health care providers.
The primary outcome measure will be change in Seattle-RAPA score at 12 months in the
intervention participants compared to the wait-listed control patients. The latter will be
offered the intervention in Year 2.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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