Trial to Incentivise Adherence for Diabetes

NCT02224417 | Completed

• 1 other identifier: NIHA-2013-1-005
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

Type II diabetes is associated with a host of adverse and costly complications, including heart attacks, strokes, blindness, kidney failure, and severe neuropathy that may result in amputations. For those with diabetes, glycemic control is essential to minimize complications but many fail at being sufficiently adherent to their treatment. The investigators propose to test two incentive-based intervention strategies aimed at improving diabetes outcomes amongst patients with uncontrolled glycemic levels. The incentives are tied either to processes aimed at improving blood sugar levels (glucose testing, physical activity and medication adherence) or directly to the intermediary outcome (blood glucose in the acceptable range). While process incentives are likely to provide more motivation for treatment adherence, as these goals may be comparably easier to meet, these incentives only reward intermediary outcomes and it might be more effective to reward successfully achieving a health outcome directly.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Treatment medication adherence; Physical activity; Financial incentives; Outcome incentives; Process incentives; HbA1c

Outcome Measures

Primary Outcomes (1)

• HbA1c levels

  HbA1c levels will be the health outcome variable. HbA1c measures the metabolic control of diabetes, with normal values (well controlled blood glucose levels) below 7%. We hypothesise that participants with high adherence levels will have lower HbA1c levels and be more likely to have healthy (below 7%) HbA1c levels compared to less adherent participants, all being equal.

  Baseline, Week 12 and Week 24

Secondary Outcomes (4)

• Physical activity

  Months 1 to 6

• Medication Adherence

  Months 1 to 6

• Glucose testing rates

  Months 1 to 6

• Glucose testing within range

  Months 1 to 6

Study Arms (3)

Diabetes Educational Program (DEP) only

OTHER

Participants will receive the Diabetes Educational Program, as required, which is part of usual care at the Polyclinic. They will receive the Fitbit ™, the eCAP, and a glucometer (if they do not already have one).

Behavioral: Diabetes Educational Program (DEP)

DEP + Process Incentive Arm

OTHER

Participants will receive the Diabetes Educational Program, as required. They will receive the Fitbit ™, the eCAP, and a glucometer (if they do not already have one). They will also have the opportunity to earn financial incentives for meeting specified process goals.

Behavioral: Diabetes Educational Program (DEP); Behavioral: DEP + Process Incentive

DEP + Outcome Incentive Arm

OTHER

Participants will receive the Diabetes Educational Program, as required. They will receive the Fitbit ™, the eCAP, and a glucometer (if they do not already have one). They will also have the opportunity to earn financial incentives for meeting specified outcome goals.

Behavioral: Diabetes Educational Program (DEP); Behavioral: DEP + Outcome Incentive

Interventions

Diabetes Educational Program (DEP) BEHAVIORAL

Participants in this Arm will receive the Diabetes Educational Program (DEP), as required, which is part of usual care at the Polyclinic. It is delivered by a Health Counsellor at the point of diagnosis and focused education is provided during doctor visits for medication. The program at the Polyclinic comprises information on a series of diabetes-related issues. The participant will receive the 2 or 3 study devices (patients will receive a glucometer if they do not already have one). The Site Study Coordinator will provide education on the use of the Fitbit Zip™ and the eCAP™. As part of usual care, patients who have difficulties with their glucometer will be referred to a Health Counsellor at the Polyclinic.

DEP + Outcome Incentive Arm; DEP + Process Incentive Arm; Diabetes Educational Program (DEP) only

DEP + Process Incentive BEHAVIORAL

Participants will receive the DEP as required. In addition, participants will have the opportunity to earn financial incentives (in vouchers) for meeting specified goals: * SGD3.50 weekly for meeting Glucose testing goals: measuring blood glucose on three non-consecutive days each week. * SGD0.50 daily for Medication adherence: taking medications daily as prescribed, monitored by eCAP device. Assessed based on medication-taking times within specified time windows. Participants should be adherent at all specified mealtimes to be fully adherent for the day. * SGD1.00 daily for Regular Physical activity: taking 8,000 steps during the day as recorded by Fitbit.

DEP + Process Incentive Arm

DEP + Outcome Incentive BEHAVIORAL

Participants will receive the DEP as required. In addition, participants will have the opportunity to earn financial incentives (in vouchers) for recording glucose readings within the normal range (i.e. between 4 to 7mmols/L two before a meal) on 3 non-consecutive days within the week using the glucometer. * SGD 2 weekly if one glucose readings falls within the normal range, * SGD 7 weekly if two glucose readings fall within the normal range, * SGD 14 weekly if all three glucose readings fall within the normal range.

DEP + Outcome Incentive Arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants need to be uncontrolled diabetics at Baseline. Uncontrolled diabetes is defined by a HbA1c level 8.0 or greater. Participants will be required to have at least 1 of 2 HbA1c readings 8.0 or greater in the past 6 months.
• Be prescribed at least one diabetic medication for at least three months and be willing to have this verified by a physician.
• Be Singaporean citizens or Permanent Residents.
• Be able to converse in English or Mandarin.

You may not qualify if:

• Individuals on inject-able insulin therapy.
• Individuals with significant co-morbid conditions such that they are unlikely to be able to take their medications without assistance from a third party.
• Individuals who are pregnant.
• Individuals who fail the PARQ and do not obtain doctor's consent.

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead

Study Sites (2)

SingHealth Polyclinics (Geylang)

Singapore, 389707, Singapore

Location

SingHealth Polyclinic (Bedok)

Singapore, 469662, Singapore

Location

Related Publications (19)

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• Thomas DE, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD002968. doi: 10.1002/14651858.CD002968.pub2.

  PMID: 16855995 BACKGROUND

• Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.

  PMID: 21540423 BACKGROUND

• Parker B, Noakes M, Luscombe N, Clifton P. Effect of a high-protein, high-monounsaturated fat weight loss diet on glycemic control and lipid levels in type 2 diabetes. Diabetes Care. 2002 Mar;25(3):425-30. doi: 10.2337/diacare.25.3.425.

  PMID: 11874925 BACKGROUND

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  PMID: 15908846 BACKGROUND

• Chapman GB, Brewer NT, Coups EJ, Brownlee S, Leventhal H, Leventhal EA. Value for the future and preventive health behavior. J Exp Psychol Appl. 2001 Sep;7(3):235-50.

  PMID: 11676102 BACKGROUND

• Elliott RA, Shinogle JA, Peele P, Bhosle M, Hughes DA. Understanding medication compliance and persistence from an economics perspective. Value Health. 2008 Jul-Aug;11(4):600-10. doi: 10.1111/j.1524-4733.2007.00304.x. Epub 2008 Jan 8.

  PMID: 18194403 BACKGROUND

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  PMID: 22580095 BACKGROUND

• Giuffrida A, Torgerson DJ. Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ. 1997 Sep 20;315(7110):703-7. doi: 10.1136/bmj.315.7110.703.

  PMID: 9314754 BACKGROUND

• Johnston M, Sniehotta F. Financial incentives to change patient behaviour. J Health Serv Res Policy. 2010 Jul;15(3):131-2. doi: 10.1258/jhsrp.2010.010048. No abstract available.

  PMID: 20555040 BACKGROUND

• Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.

  PMID: 19066383 BACKGROUND

• Ainslie G. Specious reward: a behavioral theory of impulsiveness and impulse control. Psychol Bull. 1975 Jul;82(4):463-96. doi: 10.1037/h0076860. No abstract available.

  PMID: 1099599 BACKGROUND

• Chernew ME, Juster IA, Shah M, Wegh A, Rosenberg S, Rosen AB, Sokol MC, Yu-Isenberg K, Fendrick AM. Evidence that value-based insurance can be effective. Health Aff (Millwood). 2010 Mar-Apr;29(3):530-6. doi: 10.1377/hlthaff.2009.0119. Epub 2010 Jan 21.

  PMID: 20093294 BACKGROUND

• Doshi JA, Zhu J, Lee BY, Kimmel SE, Volpp KG. Impact of a prescription copayment increase on lipid-lowering medication adherence in veterans. Circulation. 2009 Jan 27;119(3):390-7. doi: 10.1161/CIRCULATIONAHA.108.783944. Epub 2009 Jan 12.

  PMID: 19139387 BACKGROUND

• Maciejewski ML, Farley JF, Parker J, Wansink D. Copayment reductions generate greater medication adherence in targeted patients. Health Aff (Millwood). 2010 Nov;29(11):2002-8. doi: 10.1377/hlthaff.2010.0571.

  PMID: 21041739 BACKGROUND

• Sjostrom CD, Lissner L, Wedel H, Sjostrom L. Reduction in incidence of diabetes, hypertension and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS Intervention Study. Obes Res. 1999 Sep;7(5):477-84. doi: 10.1002/j.1550-8528.1999.tb00436.x.

  PMID: 10509605 BACKGROUND

• Bilger M, Shah M, Tan NC, Tan CYL, Bundoc FG, Bairavi J, Finkelstein EA. Process- and Outcome-Based Financial Incentives to Improve Self-Management and Glycemic Control in People with Type 2 Diabetes in Singapore: A Randomized Controlled Trial. Patient. 2021 Sep;14(5):555-567. doi: 10.1007/s40271-020-00491-y. Epub 2021 Jan 25.

  PMID: 33491116 DERIVED

• Bilger M, Shah M, Tan NC, Howard KL, Xu HY, Lamoureux EL, Finkelstein EA. Trial to Incentivise Adherence for Diabetes (TRIAD): study protocol for a randomised controlled trial. Trials. 2017 Nov 17;18(1):551. doi: 10.1186/s13063-017-2288-6.

  PMID: 29149912 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Interventions

1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Marcel Bilger

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 25, 2014
• Study Start: March 1, 2015
• Primary Completion: October 25, 2018
• Study Completion: October 31, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

SG (2)