This trial is active, not recruiting.

Condition type 2 diabetes
Treatment community health worker intervention
Sponsor Public Health - Seattle and King County
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date November 2011
End date April 2015
Trial size 287 participants
Trial identifier NCT02152852, 5R18DK088072


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Community Health Worker Intervention-home visits from community health workers providing education and support for self-management of type 2 diabetes, resources for diabetes control, and assistance in effective communication with medical providers
community health worker intervention
For the intervention group, a trained Community Health Worker (CHW) will provide education, support and service coordination through in-home visits. The CHW will first make an in-home assessment visit. At the assessment visit, the participant has the opportunity to ask questions and sign written consent. During this visit, the CHW assesses the participant's history with diabetes, medication adherence, self-management activities, healthcare utilization and will administer a finger stick blood test for HbA1c and a full lipid panel. After enrollment, the participant receives up to five follow-up educational visits 0.5, 1.5, 3.5, 7 and 10 months later. In addition to scheduled visits, the CHWs work with their participants on an as-needed basis via telephone, or additional home visits.
(No Intervention)
Usual Care Control Group- Usual care is defined as services 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) and educational pamphlets.

Primary Outcomes

Improvement in HbA1c
time frame: One Year

Secondary Outcomes

Improvement in lipids
time frame: One Year
Improvement in blood pressure
time frame: One Year
Healthcare Utilization
time frame: One Year
Physical and mental functioning
time frame: One year

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title Peer Support for Achieving Independence in Diabetes (Peer AID)
Principal investigator Karin Nelson, MD, MSHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Public Health - Seattle and King County.