Clinical trial NCT02152852: Peer Support for Achieving Independence in Diabetes
Official title: Peer Support for Achieving Independence in Diabetes (Peer AID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Lead sponsor: Public Health - Seattle and King County
Sponsor class: OTHER_GOV
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-06-02
Enrollment: 287
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in HbA1c
timeFrame: One Year
Secondary outcomes:
measure: Improvement in lipids
timeFrame: One Year
measure: Improvement in blood pressure
timeFrame: One Year
measure: Healthcare Utilization
timeFrame: One Year
measure: Physical and mental functioning
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: VA Puget Sound
name: Karin Nelson, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Public Health Seattle King County
name: James Krieger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: