Peer Support for Achieving Independence in Diabetes (Peer-AID)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community Health Worker Intervention
Sponsored by

About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Type 2 Diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Community Health Worker Intervention
Usual Care Control Group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Improvement in HbA1c
HbA1c will be assessed at baseline and then again at 12 months.
Secondary Outcome Measures
Improvement in lipids
Lipids will be assessed at baseline and again at 12 months.
Improvement in blood pressure
Will assess blood pressure at baseline and 12 months.
Healthcare Utilization
Will assess healthcare utilization at baseline and at 12 months.
Physical and mental functioning
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.
Full Information
NCT ID
NCT02152852
First Posted
May 23, 2014
Last Updated
April 12, 2017
Sponsor
Public Health - Seattle and King County
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02152852
Brief Title
Peer Support for Achieving Independence in Diabetes
Acronym
Peer-AID
Official Title
Peer Support for Achieving Independence in Diabetes (Peer AID)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health - Seattle and King County
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community Health Worker Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in HbA1c
Description
HbA1c will be assessed at baseline and then again at 12 months.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Improvement in lipids
Description
Lipids will be assessed at baseline and again at 12 months.
Time Frame
One Year
Title
Improvement in blood pressure
Description
Will assess blood pressure at baseline and 12 months.
Time Frame
One Year
Title
Healthcare Utilization
Description
Will assess healthcare utilization at baseline and at 12 months.
Time Frame
One Year
Title
Physical and mental functioning
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Nelson, MD, MSHS
Organizational Affiliation
VA Puget Sound
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Krieger, MD, MPH
Organizational Affiliation
Public Health Seattle King County
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Peer Support for Achieving Independence in Diabetes
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