Diabetes MellitusNCT01125969
A Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes
A study testing Incentives, Education and Peer mentoring in people with Diabetes Mellitus, run by University of Pennsylvania at 1 site in United States.
Trial summary
In recent years, social networks have garnered attention in both academic journals and the lay press because of strong associations demonstrated in retrospective studies between social networks and incidence of major health problems such as obesity and smoking. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Incentives, Education and Peer mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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
- diagnosed with diabetes mellitus
- 30 to 70 years old
- persistently poor glucose control, defined as having the last two HbA1c values > 8%, with at least one measure within 3 months of enrollment
- receiving treatment for diabetes mellitus at one of five University of Pennsylvania outpatient clinics
Who cannot join
- does not speak English
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes
In recent years, social networks have garnered attention in both academic journals and the lay press because of strong associations demonstrated in retrospective studies between social networks and incidence of major health problems such as obesity and smoking. Financial incentives have also been demonstrated to improve health behaviors in obesity, smoking, and medication adherence. We propose to conduct a randomized controlled trial among a predominantly African American population with persistently poor diabetes mellitus (DM) control to examine whether two novel interventions, lottery based financial incentives and telephone based one-on-one peer mentoring (the 'buddy system'), can significantly ameliorate disparities in poor DM control.
The intervention is based on epidemiologic evidence, randomized controlled trials, and pilot studies demonstrating: 1) Lottery based financial incentives are a powerful motivator of behavior change; 2) One-on-one peer mentoring is a flexible, cost-efficient means of increasing DM specific social support and may be particularly salient in minority communities; and 3) Matching patients with poorly controlled DM with a similar individual from their community who has gained control of their DM draws on existing community assets in creating an inherently culturally competent intervention. DM patients with poor DM control will be randomized to 1 of 4 arms: usual care; telephone based one-on-one peer mentoring; lottery based financial incentives; and peer mentoring plus financial incentives.
Read more
The Specific Aims are to test: 1) The effectiveness of telephone based one-on-one peer mentoring in improving glycemic control relative to usual care; 2) The effectiveness of lottery based financial incentives in improving glycemic control relative to usual care; 3) The effectiveness of combining peer mentoring and financial incentives relative to control; and 4) The relative cost effectiveness of all four approaches. In exploratory analyses, we will examine whether African American patients enrolled in intervention arms have greater improvement in glycemic control than white patients, whether intervention group patients experience greater improvements in blood pressure (BP) and lipid control, and whether peer mentors experience improvements in their own health. We will pair mentors with mentees based on race, gender, age, and disease severity. The active intervention will be run for a 6-month time period, with participants followed for an additional 6 months to determine if effects persist post intervention.
The proposed interventions address multiple barriers to effective disease management common among patients with DM. If effective, these interventions could provide important models for improving glycemic control in general and, in particular, for addressing racial disparities in DM outcomes.
- Conditions
- Diabetes Mellitus
- Being tested
- Incentives, Education, Peer mentoring
- Keywords
- diabetes, glucose, peer mentor, incentives, behavioral economics, cost-effectiveness
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncentivesBehavioural
Incentives will be offered for checking blood glucose each morning and for control of blood glucose (between 80-140 mg/dL).
EducationBehavioural
Standard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia
Peer mentoringBehavioural
Participant is assigned a peer mentor who is matched on gender, race and age and who achieved good glucose control after previously having poor glucose control.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Behavioral: Education |
| Incentive | Experimental | Not described Receives: Behavioral: Incentives; Behavioral: Education |
| Peer Mentoring | Experimental | Not described Receives: Behavioral: Education; Behavioral: Peer mentoring |
| Incentives and Peer Mentoring | Experimental | Not described Receives: Behavioral: Incentives; Behavioral: Education; Behavioral: Peer mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
HbA1c is a measure of the percent of glycosylated hemoglobin in the blood stream. It is an excellent biomarker reflecting glucose control for the preceding 2-3 months and thus provides a reliable and unbiased marker of patient adherence. The primary outcome will be a change in HbA1c from baseline to the 6-month follow-up visit.
Measured: Baseline, 6 months
Secondary outcomes (1)
Cost-effectiveness of change in Hemoglobin A1c
A "within-trial" analysis will be conducted that adopts the perspective of an insurer and directly compares costs and change in HbA1c using data measured in the trial.
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 startMar 2011
- Primary completionDec 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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Judith A. Long, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125969
- Sponsor's protocol ID
- 10022605
- Status last verified
- Aug 2018
- First submitted
- 13 Apr 2010
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes
- ClinicalTrials.gov ID
- NCT01125969
- Acronym / sponsor ID
- 10022605
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, glucose, peer mentor, incentives, behavioral economics, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (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.
In recent years, social networks have garnered attention in both academic journals and the lay press because of strong associations demonstrated in retrospective studies between social networks and incidence of major health problems such as obesity and smoking. Financial incentives have also been demonstrated to improve health behaviors in obesity, smoking, and medication adherence. We propose to conduct a randomized controlled trial among a predominantly African American population with persistently poor diabetes mellitus (DM) control to examine whether two novel interventions, lottery based financial incentives and telephone based one-on-one peer mentoring (the 'buddy system'), can significantly ameliorate disparities in poor DM control.
The intervention is based on epidemiologic evidence, randomized controlled trials, and pilot studies demonstrating: 1) Lottery based financial incentives are a powerful motivator of behavior change; 2) One-on-one peer mentoring is a flexible, cost-efficient means of increasing DM specific social support and may be particularly salient in minority communities; and 3) Matching patients with poorly controlled DM with a similar individual from their community who has gained control of their DM draws on existing community assets in creating an inherently culturally competent intervention. DM patients with poor DM control will be randomized to 1 of 4 arms: usual care; telephone based one-on-one peer mentoring; lottery based financial incentives; and peer mentoring plus financial incentives.
The Specific Aims are to test: 1) The effectiveness of telephone based one-on-one peer mentoring in improving glycemic control relative to usual care; 2) The effectiveness of lottery based financial incentives in improving glycemic control relative to usual care; 3) The effectiveness of combining peer mentoring and financial incentives relative to control; and 4) The relative cost effectiveness of all four approaches. In exploratory analyses, we will examine whether African American patients enrolled in intervention arms have greater improvement in glycemic control than white patients, whether intervention group patients experience greater improvements in blood pressure (BP) and lipid control, and whether peer mentors experience improvements in their own health. We will pair mentors with mentees based on race, gender, age, and disease severity. The active intervention will be run for a 6-month time period, with participants followed for an additional 6 months to determine if effects persist post intervention.
The proposed interventions address multiple barriers to effective disease management common among patients with DM. If effective, these interventions could provide important models for improving glycemic control in general and, in particular, for addressing racial disparities in DM outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Education |
| Incentive | Experimental | Behavioral: Incentives, Behavioral: Education |
| Peer Mentoring | Experimental | Behavioral: Education, Behavioral: Peer mentoring |
| Incentives and Peer Mentoring | Experimental | Behavioral: Incentives, Behavioral: Education, Behavioral: Peer mentoring |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with diabetes mellitus
- 30 to 70 years old
- persistently poor glucose control, defined as having the last two HbA1c values > 8%, with at least one measure within 3 months of enrollment
- receiving treatment for diabetes mellitus at one of five University of Pennsylvania outpatient clinics
Key exclusion criteria (2 listed)
- does not speak English
- unable to provide informed consent
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 |
|---|---|---|
| IncentivesIncentives will be offered for checking blood glucose each morning and for control of blood glucose (between 80-140 mg/dL). | Behavioural | Incentive, Incentives and Peer Mentoring |
| EducationStandard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia | Behavioural | Control, Incentive, Incentives and Peer Mentoring, Peer Mentoring |
| Peer mentoringParticipant is assigned a peer mentor who is matched on gender, race and age and who achieved good glucose control after previously having poor glucose control. | Behavioural | Incentives and Peer Mentoring, Peer Mentoring |
Primary outcome
Hemoglobin A1c
Time frame: Baseline, 6 months
HbA1c is a measure of the percent of glycosylated hemoglobin in the blood stream. It is an excellent biomarker reflecting glucose control for the preceding 2-3 months and thus provides a reliable and unbiased marker of patient adherence. The primary outcome will be a change in HbA1c from baseline to the 6-month follow-up visit.
1 secondary outcome
Cost-effectiveness of change in Hemoglobin A1c
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 7 Aug 2018.
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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 A. 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 Incentives, Education and Peer mentoring 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 4 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 7 Aug 2018. 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?
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 7 Aug 2018.