Type 2 DiabetesPeer-AIDNCT02152852
Peer Support for Achieving Independence in Diabetes
A study testing Community Health Worker Intervention in people with Type 2 Diabetes, run by Public Health - Seattle and King County.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Community Health Worker Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Peer Support for Achieving Independence in Diabetes (Peer AID)
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.
Read the 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
- Being tested
- Community Health Worker Intervention
- Keywords
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Intervention | Experimental | 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 Receives: Behavioral: Community Health Worker Intervention |
| Usual Care Control Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in HbA1c
HbA1c will be assessed at baseline and then again at 12 months.
Measured: One Year
Secondary outcomes (4)
Improvement in lipids
Lipids will be assessed at baseline and again at 12 months.
Measured: One Year
Improvement in blood pressure
Will assess blood pressure at baseline and 12 months.
Measured: One Year
Healthcare Utilization
Will assess healthcare utilization at baseline and at 12 months.
Measured: One Year
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startNov 2011
- Primary completionApr 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health - Seattle and King County
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karin Nelson, MD, MSHS, Principal investigator, VA Puget SoundJames Krieger, MD, MPH, Principal investigator, Public Health Seattle King County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152852
- Sponsor's protocol ID
- 5R18DK088072
- Other IDs
- 5R18DK088072
- Acronym
- Peer-AID
- Status last verified
- Apr 2017
- First submitted
- 23 May 2014
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support for Achieving Independence in Diabetes (Peer AID)
- ClinicalTrials.gov ID
- NCT02152852
- Acronym / sponsor ID
- Peer-AID / 5R18DK088072
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Public Health - Seattle and King CountyOther government
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Intervention | Experimental | Behavioral: Community Health Worker InterventionCommunity 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 | 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker InterventionFor 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. | Behavioural | Community Health Worker Intervention |
Primary outcome
Improvement in HbA1c
Time frame: One Year
HbA1c will be assessed at baseline and then again at 12 months.
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Nelson, MD, MSHS principal investigator
VA Puget Sound
James Krieger, MD, MPH principal investigator
Public Health Seattle King County
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Intervention in people with Type 2 Diabetes, run by Public Health - Seattle and King County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in HbA1c (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.