Peer Support for Achieving Independence in Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT02152852
• Lead Sponsor: Public Health - Seattle and King County

Brief Summary

The purpose of this study is to test the hypotheses that CHWs providing in-home support for self-management of type 2 diabetes, resources for diabetes, and assistance in effective linkage and communication with medical providers will: (1) improve HbA1c (primary outcome) and secondary outcomes including lipids, blood pressure, health care utilization, and health-related quality of life; (2) improve diabetes self-management, including self-efficacy, physical activity, nutrition, and medication adherence; and (3) be cost-effective and feasible.

Detailed Description

The investigators will implement a randomized trial that will enroll 286 participants, from three different sites, to compare a CHW intervention consisting of home visits, telephone support, and linkage to appropriate community-based group activities compared to usual care. Usual care is defined as the medical care received by participants in the absence of the intervention plus information about community resources that support diabetes self-management (such as classes and support groups) plus educational pamphlets. The investigators will randomize an equal number of participants to the intervention and control groups.

After collecting baseline data, we will assign participants to study groups using a stratified, permuted block design with varying block size. The investigators will stratify by site to ensure an approximately equal number of treatment and control subjects at each site and also meet the site-specific recruitment targets. The nature of the intervention makes it impossible to blind participants and staff to group assignment.

CHWs will primarily work with participants in their homes, and will also link them to community resources that support self-management. CHWs will make up to 5 home visits for each participant in the intervention arm. To assure that the program is feasible to implement in a variety of clinical settings, to assure external validity of the study, and to assess potential for adoption, the CHWs will be based at the local public health department and participants will be recruited from a county hospital system, a community clinic and a Veteran Affairs (VA) hospital.

Specific aims of the proposal are to examine the effect of the intervention on physiologic markers of disease control (HbA1c, lipids, blood pressure), participant self-efficacy, self-management behaviors quality of life and utilization and costs. The investigators will measure other demographic, medical and psychosocial patient level characteristics that could potentially modify the effects of the intervention. At the end of the study period, CHWs will visit usual care participants so that they receive many of the potential benefits received by intervention group members.

The investigators will use mixed methods to assess translation of the research models into practice.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Primary Completion: 2015-04
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Diagnosis of type 2 diabetes and HbA1c of 8.0% or greater
• Household income less than 250% of the federal poverty level
• Residence within target area of King County, Washington
• Age 30-70 years.
• Primary language spoken by participant is English or Spanish

Exclusion Criteria

• Type 1 diabetes
• Pregnant
• Unable to provide informed consent
• End-stage renal disease (ESRD), dementia, or a terminal illness
• Plans to move within the next two years or is homeless
• Other mental or physical disability making it impossible to participate in the protocols

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in HbA1c	One Year	HbA1c will be assessed at baseline and then again at 12 months.

Secondary Outcome Measures

Name	Time	Method
Healthcare Utilization	One Year	Will assess healthcare utilization at baseline and at 12 months.
Physical and mental functioning	One year	The project will assess changes in physical and mental functioning at baseline and again at 12 months. The measure used will be the Short Form (SF)-12, a 12-question survey that asks participants to recall their physical and mental status over a four week time frame. Changes measured include: role limitations caused by physical health, emotional problems, physical functioning, and general health over a four week period.
Improvement in blood pressure	One Year	Will assess blood pressure at baseline and 12 months.
Improvement in lipids	One Year	Lipids will be assessed at baseline and again at 12 months.