AzTrials
AzTrials

Diabetes MellitusNCT02193984

Alliance to Control Diabetes

A study testing Peer support in people with Diabetes Mellitus, run by San Diego State University at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family Physicians Foundation. The study was designed to help patients better manage their diabetes, and was a partnership between the Institute for Behavioral and Community Health and Clínicas de Salud del Pueblo, Inc (CDSDP), a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Peer support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
2 sitesUnited States
Study dates
Feb 2009to Sep 2017
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be at least 18 years old
  • Must be diagnosed with Diabetes Mellitus Type I, Diabetes Mellitus Type II or Gestational Diabetes
  • Must be a resident of Imperial County
  • Must be a current patient of Clínicas de Salud del Pueblo, Inc., at one of the three participating clinics
  • Must speak Spanish and/or English
  • Must plan on remaining in Imperial County for at least 12 months after enrollment into the study

Who cannot join

  • Must not be involved in any other diabetes-related study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • San Diego State University Research Foundation

    Calexico, California, 92232

  • San Diego State University Research Foundation

    San Diego, California, 92123

Other trials in United States

About this study

Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family Physicians Foundation. The study was designed to help patients better manage their diabetes, and was a partnership between the Institute for Behavioral and Community Health and Clínicas de Salud del Pueblo, Inc (CDSDP), a private, non-profit corporation providing comprehensive primary care services to residents throughout Imperial and Riverside Counties, California. The investigators identified 336 patients with uncontrolled diabetes from three CDSDP clinics. Patients were randomly assigned to intervention or control conditions. The 12-month intervention consisted of individual diabetes management support delivered by a trained volunteer peer supporter. The primary aim was determine if peer support can help patients better manage their diabetes and improve the quality of their lives. Intervention effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and 12 months. This study was part of the global Peers for Progress network which has been testing peer support programs in 13 countries.

Being tested
Peer support
Keywords
Diabetes, Peer support, Hispanic, Latino
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer supportBehavioural

Study groups in NCT02193984
Study groupRoleWhat they receive
Peer supportExperimentalStudy participants are assigned a volunteer peer supporter who has been trained to offer support on diabetes management.
Receives: Behavioral: Peer support
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HbA1c levels.

    Changes in HbA1c levels of diabetes patients from baseline to 12 months as assessed by medical chart review of blood draw results.

    Measured: Baseline, 6 months, 12 months

Secondary outcomes (5)

  1. Changes in blood pressure.

    Changes in blood pressure of diabetes patients from baseline to 12 months as assessed by medical chart review.

    Measured: Baseline, 6 months, 12 months

  2. Changes in cholesterol.

    Changes in cholesterol of diabetes patients from baseline to 12 months as assessed by medical chart review.

    Measured: Baseline, 6 months, 12 months

  3. Changes in HDL, LDL and triglycerides.

    Changes in HDL, LDL and triglycerides of diabetes patients from baseline to 12 months as assessed by medical chart review.

    Measured: Baseline, 6 months, 12 months

  4. Changes in depression.

    Changes in depression of diabetes patients from baseline to 12 months as assessed by self-report via interview with a trained research assistant in the participant's language of choice (Spanish or English).

    Measured: Baseline, 6 months, 12 months

  5. Changes in distress.

    Changes in distress of diabetes patients from baseline to 12 months as assessed by self-report via interview with a trained research assistant in the participant's language of choice (Spanish or English).

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2014 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2012
  4. Study completionSep 2017 (estimated)

Resources

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
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02193984
Sponsor's protocol ID
G00007943
Status last verified
Jan 2017
First submitted
16 Jul 2014
Last updated
13 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Fisher EB, Ayala GX, Ibarra L, Cherrington AL, Elder JP, Tang TS, Heisler M, Safford MM, Simmons D; Peers for Progress Investigator Group. Contributions of Peer Support to Health, Health Care, and Prevention: Papers from Peers for Progress. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S2-8. doi: 10.1370/afm.1852.

    PubMed 26304968

  • Simmons D, Bunn C, Nakwagala F, Safford MM, Ayala GX, Riddell M, Graffy J, Fisher EB. Challenges in the Ethical Review of Peer Support Interventions. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S79-86. doi: 10.1370/afm.1803.

    PubMed 26304976

  • Parada H Jr, Horton LA, Cherrington A, Ibarra L, Ayala GX. Correlates of medication nonadherence among Latinos with type 2 diabetes. Diabetes Educ. 2012 Jul-Aug;38(4):552-61. doi: 10.1177/0145721712445215. Epub 2012 Apr 30.

    PubMed 22546741

  • Ayala GX, Ibarra L, Cherrington AL, Parada H, Horton L, Ji M, Elder JP. Puentes hacia una mejor vida (Bridges to a Better Life): Outcome of a Diabetes Control Peer Support Intervention. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S9-17. doi: 10.1370/afm.1807.

    PubMed 26304977

  • Soto SC, Louie SY, Cherrington AL, Parada H, Horton LA, Ayala GX. An ecological perspective on diabetes self-care support, self-management behaviors, and hemoglobin A1C among Latinos. Diabetes Educ. 2015 Apr;41(2):214-23. doi: 10.1177/0145721715569078. Epub 2015 Feb 5.

    PubMed 25656696

Questions about this trial

What is this clinical trial studying?

A study testing Peer support in people with Diabetes Mellitus, run by San Diego State University at 2 sites in United States.

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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

Changes in HbA1c levels. (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02193984, which also lists 5 linked publications.

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 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in