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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
Public Health - Seattle and King County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Type 2 Diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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)
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    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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