Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-31 @ 1:56 AM
Study NCT ID:
NCT01282957
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2011-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Way to Health, Healthy Measures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-21', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of use of the three home-based technologies', 'timeFrame': '3-months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Usability and functionality of the study's online web portal, Way to Health, and wifi-enabled home health monitoring devices", 'timeFrame': '6-months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '19213683', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19066383', 'type': 'BACKGROUND', 'citation': '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': '19102784', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24522623', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 18 and 80 years of age\n* Hemoglobin A1c measured in the last six weeks greater than or equal to 7.5%\n* Weight less than 425lbs\n* Cell phone with text messaging capabilities or email access\n* Followed by Primary Care Provider at Penn Internal Medicine Associates practice at 3701 Market St\n\nExclusion Criteria:\n\n* Lack or are unwilling to use email or cell phone for text messaging\n* Are enrolled in other, ongoing clinical trials\n* Suffer from an uncontrolled psychiatric disease\n* 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)'}, 'identificationModule': {'nctId': 'NCT01282957', 'briefTitle': 'Way to Health, Healthy Measures', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Financial Incentives for Home-based Health Management: A Pilot Randomized Trial', 'orgStudyIdInfo': {'id': '812211'}, 'secondaryIdInfos': [{'id': 'RC2AG036592', 'link': 'https://reporter.nih.gov/quickSearch/RC2AG036592', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Active Control', 'description': 'Daily use of three home-monitoring devices: glucometer, blood pressure cuff and scale for 6 months'}, {'type': 'EXPERIMENTAL', 'label': 'Financial Incentive Group I', 'description': '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.)', 'interventionNames': ['Behavioral: Financial Incentive Group I']}, {'type': 'EXPERIMENTAL', 'label': 'Financial Incentives Group II', 'description': '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.)', 'interventionNames': ['Behavioral: Financial Incentive Group II']}], 'interventions': [{'name': 'Financial Incentive Group I', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Financial Incentive Group I']}, {'name': 'Financial Incentive Group II', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Financial Incentives Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kevin Volpp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}