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CompletedNCT01282957Updated Aug 25, 2016

Way to Health, Healthy Measures

An interventional study of Financial Incentive Group I and Financial Incentive Group II in Diabetes and Hypertension, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-25.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The primary objective of the study is to assess the effect of financial incentives on the use of home health monitoring devices among high-risk patients. In addition, there are three secondary objectives: (1) obtain preliminary evidence regarding whether the monetary value of incentives has a differential effect on the use of home health monitoring devices; (2) identify potential barriers that prohibit regular use of home-based health devices using qualitative data; and (3) assess the usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors.

Read the detailed description

While home monitoring of health appears to be a promising frontier in health care, patient adherence to, and utilization of, such devices is often low, limiting the potential benefit of this technology. Financial incentives have been effective in increasing rates of weight loss, smoking cessation, and medication adherence and therefore may increase rates of utilization of home-based health monitoring devices. Therefore, in this study, we test the effects of lottery-based incentives on use of home-based health monitoring technologies.

The aim of this pilot randomized controlled trial is to evaluate whether financial incentives delivered through a novel online platform can effectively increase use of home-based health monitoring technology among overweight adults with diabetes. Our primary objective is to assess the effects of financial incentives on the use of home health monitoring devices among high-risk patients. In addition, we have three secondary objectives: (1) obtain preliminary evidence regarding whether the monetary value of incentives has a differential effect on the use of home health monitoring devices; (2) identify potential barriers that prohibit regular use of home-based health devices using qualitative data; and (3) assess the usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors.

Participants will be randomized into each of the following three arms: (1) Financial Incentive Group I; (2) Financial Incentive Group II; (3) Control Group. Incentives for Financial Groups I and II are designed in a way that builds on the success of previous incentive-based interventions for weight loss. Both lotteries are tailored to provide infrequent large payoffs and frequent small payoffs since lottery players are motivated by both the possibility of a large reward and the opportunity for regular, immediate rewards. The average expected payoff value of Financial Incentive Group I will be $2.80 per day and $1.40 per day in Financial Incentive Group II. The interventions will run for 91 days starting at randomization. At the end of the intervention time period, each participant will be notified that the intervention period has ended and the 90-day follow-up period has begun. During the follow-up period each participant will continue to upload measurements daily, but will not receive incentives or reminders.

02

Conditions studied

  • Diabetes
  • Hypertension

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03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 75 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults between 18 and 80 years of age
  • Hemoglobin A1c measured in the last six weeks greater than or equal to 7.5%
  • Weight less than 425lbs
  • Cell phone with text messaging capabilities or email access
  • Followed by Primary Care Provider at Penn Internal Medicine Associates practice at 3701 Market St

Exclusion criteria

Exclusion Criteria:

  • Lack or are unwilling to use email or cell phone for text messaging
  • Are enrolled in other, ongoing clinical trials
  • Suffer from an uncontrolled psychiatric disease
  • Have a history or diagnosis of heart failure as confirmed by ICD-9 codes: 428.0 (congestive heart failure), 425.0 (cardiomyopathy), and 414.8 ischemic cardiomyopathy)
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • No intervention
    Active Control

    Daily use of three home-monitoring devices: glucometer, blood pressure cuff and scale for 6 months

  • Experimental
    Financial Incentive Group I

    Daily use of three home-monitoring devices: glucometer, blood pressure cuff and scale for 3 months. If all three devices used daily, participant entered in lottery with 1 in 100 odds of winning $100 and 2 in 10 odds of winning $10. Financial incentive terminated after 3 months. Daily use of devices continues for additional 3 months. (Intervention involves the daily lottery itself along with feedback via email or text messaging to participants about the lottery results and whether or not they were included based on device adherence.)

    Behavioral: Financial Incentive Group I

  • Experimental
    Financial Incentives Group II

    Daily use of three home-monitoring devices: glucometer, blood pressure cuff and scale for 3 months. If all three devices used daily, participant entered in lottery with 1 in 100 odds of winning $50 and 2 in 10 odds of winning $5. Financial incentive terminated after 3 months. Daily use of devices continues for additional 3 months. (Intervention involves the daily lottery itself along with feedback via email or text messaging to participants about the lottery results and whether or not they were included based on device adherence.)

    Behavioral: Financial Incentive Group II

Interventions

  • BehavioralFinancial Incentive Group I

    Lottery with 1 in 100 odds of $100 and 18 in 100 odds of $10. The intervention involves the daily lottery itself along with feedback via email or text messaging to participants about the lottery results and whether or not they were included based on device adherence.

  • BehavioralFinancial Incentive Group II

    Lottery with 1 in 100 odds of $50 and 18 in 100 odds of $5. The intervention involves the daily lottery itself along with feedback via email or text messaging to participants about the lottery results and whether or not they were included based on device adherence.

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What researchers measure

Primary outcomes

  1. Rate of use of the three home-based technologies

    We will analyze the proportion of days that home monitoring was completed (defined as successful reporting of data from all three devices - weight, blood pressure and blood sugar) compared to failure to report across all groups after the end of the 3-month intervention period.

    Time frame: 3-months

Secondary outcomes

  1. Usability and functionality of the study's online web portal, Way to Health, and wifi-enabled home health monitoring devices

    We will ask participants to participate in a qualitative interview at the final study visit to assess the usability and functionality of the web portal and study devices for use during future studies.

    Time frame: 6-months

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Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819. PubMed 19213683 ↗
  • 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. PubMed 19066383 ↗
  • Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272. PubMed 19102784 ↗
  • Sen AP, Sewell TB, Riley EB, Stearman B, Bellamy SL, Hu MF, Tao Y, Zhu J, Park JD, Loewenstein G, Asch DA, Volpp KG. Financial incentives for home-based health monitoring: a randomized controlled trial. J Gen Intern Med. 2014 May;29(5):770-7. doi: 10.1007/s11606-014-2778-0. Epub 2014 Feb 13. PubMed 24522623 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01282957
Lead sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Jan 25, 2011
Start date
Feb 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Aug 25, 2016

Study contacts

Kevin Volpp, MD, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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