Financial Incentives for Low Socioeconomic Diabetic Patients

NCT03506230 | Unknown

• 1 other identifier: 0159-15
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with uncontrolled diabetes \[glycated hemoglobin (Hba1c)\>8.5%\] from low socioeconomic status neighborhoods in Jerusalem will be recruited. They will be randomly assigned to an intervention group and a control group. The intervention group will be offered a bonus to buy their medications, 100 Israeli Shekels (ILS) (30$) each month for 3 months, if they reduce their HBA1c by 0.7% or if their HbA1c level reaches 7.5%. After 6 months they will be eligible for another bonus for one month if they improve their HbA1c by 0.3% from the previous test. The control group will buy medications as usual. All participants will be contacted by phone and will be encouraged to contact their doctor, to perform blood tests and to maintain a healthy lifestyle.

Conditions

Type2 Diabetes Mellitus

Keywords

Rewards; Medication Adherence; Health Behavior; Diabetes Mellitus; Copayments

Outcome Measures

Primary Outcomes (1)

• Differences in HbA1c after six months

  Differences between the groups in the change in HbA1c between the test at the entrance to the study and the test six months later

  Six months

Secondary Outcomes (3)

• Differences in HbA1c after three months

  3 months

• Differences in the proportion of participants who improved their HbA1c by 1% or more

  Six months

• Whether or not HbA1c test was performed at 3 months

  Two months

Other Outcomes (3)

• Whether LDL cholesterol test was performed

  Six months

• Performing a urine microalbumin test

  Six months

• Differences in the number of GP visits

  Six months

Study Arms (2)

Incentives group

EXPERIMENTAL

a bonus to buy their medications if they improve their HbA1c

Behavioral: Incentives

Standard group

NO INTERVENTION

Will buy their medications as usual

Interventions

Incentives BEHAVIORAL

A bonus to buy their medications if they reduce their HBA1c

Incentives group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes for at least 6 months
• Diabetes for a maximum of ten years
• Updated HbA1c level of between 8.5 and 11% from the last month
• Agreement to participate and sign an informed consent

You may not qualify if:

• Pregnancy
• Insulin therapy
• Psychiatric disorder from the first or second line according to the Diagnostic and Statistical Manual of mental disorders (DSM)
• Active oncology disease \[excluding squamous cell carcinoma (SCC) and basal cell carcinoma (BCC)
• Planed bariatric surgery for the next 6 months
• Cardiac hospitalization in the previous year
• A severe hypoglycemia event three months prior to allocation

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (1)

Clalit health services

Jerusalem, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 22431674 BACKGROUND

• Tarasiuk A, Reznor G, Greenberg-Dotan S, Reuveni H. Financial incentive increases CPAP acceptance in patients from low socioeconomic background. PLoS One. 2012;7(3):e33178. doi: 10.1371/journal.pone.0033178. Epub 2012 Mar 30.

  PMID: 22479368 BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Health Behavior; Diabetes Mellitus

Interventions

Fertility

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Amnon Lahad, MD, MPH

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayelet Prigozin

CONTACT

972506617448; Prigozin4@gmail.com

Michal Netz

CONTACT

+972-3-7170124; michalne3@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to the intervention group and the control group. The randomization will be in blocks of 6. In addition, the randomization will be in strata according to the level of HbA1c: 8.5% \<HbA1c\> 9.5%, 9.6%\> HbA1c\> 11%.

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 24, 2018
• Study Start: November 25, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)