Peer Support for Achieving Independence in Diabetes (Peer-AID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02152852|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Community Health Worker Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||287 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Peer Support for Achieving Independence in Diabetes (Peer AID)|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||December 2016|
Experimental: 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
Behavioral: 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 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.
- Improvement in HbA1c [ Time Frame: One Year ]HbA1c will be assessed at baseline and then again at 12 months.
- Improvement in lipids [ Time Frame: One Year ]Lipids will be assessed at baseline and again at 12 months.
- Improvement in blood pressure [ Time Frame: One Year ]Will assess blood pressure at baseline and 12 months.
- Healthcare Utilization [ Time Frame: One Year ]Will assess healthcare utilization at baseline and at 12 months.
- Physical and mental functioning [ Time Frame: One year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152852
|Principal Investigator:||Karin Nelson, MD, MSHS||VA Puget Sound|
|Principal Investigator:||James Krieger, MD, MPH||Public Health Seattle King County|