Diabetes MellitusNCT01125956
Improving Diabetes Control Through Peer Counseling and Incentives
A study testing Assigned a peer counselor and Financial incentives in people with Diabetes Mellitus, run by University of Pennsylvania at 1 site in United States.
Trial summary
The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control: 1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control). 2. Financial incentives are an effective means of reducing HbA1c. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Assigned a peer counselor and Financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2010
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American veteran
- 50-70 years old
- ICD-9CM diagnosis code consistent with DM (any ICD-9CM code starting with 250)
- For patients: last two HbA1c greater than 8% with at least one measure being within 3 months of enrollment
- For peer counselors: HbA1c of greater than 8% in the past 3 years and an HbA1c less than or equal to 7.5% within 3 months of enrollment
Who cannot join
- Unstable medical condition that would likely prevent the subject from completing the study
- Patients enrolled in Telehealth will be excluded as such enrollment does not constitute usual care
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104
About this study
The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control:
- Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).
- Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.
- Conditions
- Diabetes Mellitus
- Being tested
- Assigned a peer counselor, Financial incentives
- Keywords
- Diabetes, Diabetes mellitus, HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned a peer counselorBehavioural
Dyads will be given $20 per month if they have contact 4 or more times during a month.
Financial incentivesBehavioural
Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will receive usual diabetes care through their primary care clinicians. |
| Peer counseling | Experimental | A peer counselor will be assigned to each participant who currently has good diabetes control but had poor control in the past 3 years. Receives: Behavioral: Assigned a peer counselor |
| Financial incentives | Experimental | Patient participants in the financial incentive arm will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points. Receives: Behavioral: Financial incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Change in HbA1c from baseline will be the primary outcome measure.
Measured: Baseline, 6 months
Secondary outcomes (3)
Counts of the number of hypoglycemic events
All events and serious events related to hypoglycemia will be counted over the 6 month intervention period, including emergency room visits and hospitalizations.
Measured: 6 months
Number of peer encounters
The number of peer encounters by arm will be described.
Measured: 6 months
Experience of peer counseling
The experience of peer counseling from both poorly controlled diabetics and counselors will be described.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Long, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125956
- Sponsor's protocol ID
- 01164
- Status last verified
- Feb 2019
- First submitted
- 17 May 2010
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.
PubMed 22431674
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Control Through Peer Counseling and Incentives
- ClinicalTrials.gov ID
- NCT01125956
- Acronym / sponsor ID
- 01164
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Diabetes mellitus, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 May 2010 (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 specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control:
- Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).
- Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will receive usual diabetes care through their primary care clinicians. |
| Peer counseling | Experimental | Behavioral: Assigned a peer counselorA peer counselor will be assigned to each participant who currently has good diabetes control but had poor control in the past 3 years. |
| Financial incentives | Experimental | Behavioral: Financial incentivesPatient participants in the financial incentive arm will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- African American veteran
- 50-70 years old
- ICD-9CM diagnosis code consistent with DM (any ICD-9CM code starting with 250)
- For patients: last two HbA1c greater than 8% with at least one measure being within 3 months of enrollment
- For peer counselors: HbA1c of greater than 8% in the past 3 years and an HbA1c less than or equal to 7.5% within 3 months of enrollment
Key exclusion criteria (2 listed)
- Unstable medical condition that would likely prevent the subject from completing the study
- Patients enrolled in Telehealth will be excluded as such enrollment does not constitute usual care
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 |
|---|---|---|
| Assigned a peer counselorDyads will be given $20 per month if they have contact 4 or more times during a month. | Behavioural | Peer counseling |
| Financial incentivesParticipants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points. | Behavioural | Financial incentives |
Primary outcome
Hemoglobin A1c
Time frame: Baseline, 6 months
Change in HbA1c from baseline will be the primary outcome measure.
3 secondary outcomes
Counts of the number of hypoglycemic events
Time frame: 6 months
Number of peer encounters
Time frame: 6 months
Experience of peer counseling
Time frame: 6 months
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 28 Feb 2019.
- Derived from this study: PubMed 22431674Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.
- LDI Center for Health IncentivesLink provided by the sponsor.
- VA Center for Health Equity and Promotion (CHERP)Link provided by the sponsor.
- This research was supported by a grant from the National Institute on Aging, P30-AG036592. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Aging or the NIHLink provided by the sponsor.
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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.
Judith Long, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned a peer counselor and Financial incentives in people with Diabetes Mellitus, run by University of Pennsylvania at 1 site 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 5 inclusion and 2 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Hemoglobin A1c (time frame: Baseline, 6 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 NCT01125956, which also lists 1 linked publication.
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 28 Feb 2019.