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Way to Health, Healthy Measures

24. August 2016 aktualisiert von: University of Pennsylvania

Financial Incentives for Home-based Health Management: A Pilot Randomized Trial

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

75

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.)
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.
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.)
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of use of the three home-based technologies
Zeitfenster: 3-months
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.
3-months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Usability and functionality of the study's online web portal, Way to Health, and wifi-enabled home health monitoring devices
Zeitfenster: 6-months
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.
6-months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2011

Primärer Abschluss (Tatsächlich)

1. August 2012

Studienabschluss (Tatsächlich)

1. August 2012

Studienanmeldedaten

Zuerst eingereicht

10. Januar 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Januar 2011

Zuerst gepostet (Schätzen)

25. Januar 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

25. August 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. August 2016

Zuletzt verifiziert

1. August 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 812211
  • RC2AG036592 (US NIH Stipendium/Vertrag)

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