Way to Health, Healthy Measures
Financial Incentives for Home-based Health Management: A Pilot Randomized Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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:
- 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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:Active Control
Daily use of three home-monitoring devices: glucometer, blood pressure cuff and scale for 6 months
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実験的: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.)
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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.
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実験的: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.)
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of use of the three home-based technologies
時間枠:3-months
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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.
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3-months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Usability and functionality of the study's online web portal, Way to Health, and wifi-enabled home health monitoring devices
時間枠:6-months
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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.
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6-months
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
高血圧症の臨床試験
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University of Sao Paulo General Hospitalまだ募集していませんCOPD | 肺疾患および/または低酸素症に続発する肺高血圧症 | Pulmnary Hypertension
Financial Incentive Group Iの臨床試験
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Northern Illinois UniversityUniversity Autonoma de Santo Domingo終了しました