- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01282957
Way to Health, Healthy Measures
Financial Incentives for Home-based Health Management: A Pilot Randomized Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Active Control
Daily use of three home-monitoring devices: glucometer, blood pressure cuff and scale for 6 months
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Rate of use of the three home-based technologies
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Usability and functionality of the study's online web portal, Way to Health, and wifi-enabled home health monitoring devices
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 812211
- RC2AG036592 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Financial Incentive Group I
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Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratoriCompletatoAbusi sessuali su minori, confermati, sequelRegno Unito
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M.D. Anderson Cancer CenterCompletatoTumori pediatriciStati Uniti
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Rush University Medical CenterCompletato
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University of LisbonAssociacao Protectora dos Diabeticos de PortugalCompletato
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Kara MarlattCompletatoMenopausa | Condizioni correlate alla menopausaStati Uniti
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Greater Manchester Mental Health NHS Foundation...Manchester University NHS Foundation Trust; University of Manchester; Anna Freud... e altri collaboratoriCompletatoProblema di salute mentaleRegno Unito
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Sunnybrook Health Sciences CentreRitiratoIl focus dello studio è sugli atteggiamenti del dentista nei confronti delle misurazioni della pressione arteriosaCanada
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Ohio State UniversityNon ancora reclutamentoInvecchiamento | Focus GroupStati Uniti
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Gia MuddWest Virginia UniversityCompletatoEsperienze avverse dell'infanziaStati Uniti
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Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceNon ancora reclutamentoSiringomielia | Malformazione di ChiariFrancia