Peer Support for Achieving Independence in Diabetes

NCT ID: NCT02152852

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-12-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Community Health Worker Intervention

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

Group Type: EXPERIMENTAL

Community Health Worker Intervention

Intervention Type: BEHAVIORAL

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.

Usual Care Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Public Health - Seattle and King County

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Nelson, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound

James Krieger, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Public Health Seattle King County

Other Identifiers

5R18DK088072

Identifier Type: NIH

Identifier Source: secondary_id

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5R18DK088072

Identifier Type: NIH

Identifier Source: org_study_id

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