Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05481593
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D000071069', 'term': 'Multiple Chronic Conditions'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2022-07-27', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality-of-life', 'timeFrame': '24 Weeks', 'description': 'Enabled version of Short-Form 36 (SF-36E)'}], 'secondaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': '24 weeks', 'description': 'Godin leisure time exercise questionnaire'}, {'measure': 'Usability', 'timeFrame': '24 weeks', 'description': 'System Usability Scale'}, {'measure': 'Usability', 'timeFrame': '24 weeks', 'description': 'Health Information Technology Usability Evaluation Scale'}, {'measure': 'Medication adherence', 'timeFrame': '24 weeks', 'description': 'Medication adherence rating scale'}, {'measure': 'Medication adherence', 'timeFrame': '24 weeks', 'description': 'Turnkey Adherence Strategy Medication Adherence'}, {'measure': 'Self-efficacy for managing depression', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Emotional Distress-Depression 4a'}, {'measure': 'Self-efficacy for managing psychosocial illness', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Psychosocial illness impact 8a'}, {'measure': 'Self-efficacy for managing emotions', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Managing Emotions 4a'}, {'measure': 'Self-efficacy for managing medications', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Managing Emotions 4a'}, {'measure': 'Self-efficacy for managing social interactions', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Social Interactions 4a'}, {'measure': 'Physical Activity', 'timeFrame': '24 weeks', 'description': 'Measured via data from FitBit device (Minutes)'}, {'measure': 'Physical Activity', 'timeFrame': '24 weeks', 'description': 'Measured via data from FitBit device (Steps)'}, {'measure': 'Self-efficacy for managing symptoms', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Managing Symptoms 4a'}, {'measure': 'Self-efficacy for managing daily activities', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Managing daily activities 4a'}, {'measure': 'Self-efficacy for managing sleep disturbance', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Sleep Disturbance 4a'}, {'measure': 'Self-efficacy for managing sleep-related impairments', 'timeFrame': '24 weeks', 'description': 'PROMIS SF v1.0 Sleep-related impairment'}, {'measure': 'Dietary Intake', 'timeFrame': '24 weeks', 'description': 'Short Healthy Eating Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disability Physical', 'Chronic Condition', 'Chronic Conditions, Multiple']}, 'referencesModule': {'references': [{'pmid': '38345845', 'type': 'DERIVED', 'citation': 'Evans E, Zengul A, Subhash Chilke T, Knight A, Willig A, Cherrington A, Mehta T, Thirumalai M. Telehealth Behavioral Intervention for Chronic Disease Self-Management in Adults With Physical Disabilities (My Health, My Life, My Way): Protocol for Intervention Fidelity and Dashboard Design for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 12;13:e53410. doi: 10.2196/53410.'}, {'pmid': '38109170', 'type': 'DERIVED', 'citation': "Evans E, Zengul A, Knight A, Willig A, Cherrington A, Mehta T, Thirumalai M. Stakeholders' Perspectives, Needs, and Barriers to Self-Management for People With Physical Disabilities Experiencing Chronic Conditions: Focus Group Study. JMIR Rehabil Assist Technol. 2023 Dec 18;10:e43309. doi: 10.2196/43309."}, {'pmid': '37115620', 'type': 'DERIVED', 'citation': 'Evans E, Zengul A, Knight A, Willig A, Cherrington A, Mehta T, Thirumalai M. My Health, My Life, My Way-An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study. JMIR Res Protoc. 2023 Apr 28;12:e31694. doi: 10.2196/31694.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study to pilot test an accessible and inclusive artificial intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4CHRON) for health-related quality of life for adults with impaired mobility and chronic medical conditions.', 'detailedDescription': 'The AI4CHRON study will use a four-arm randomized control trial design. Eligible and consented participants will be assigned to one of four groups: 1) Scheduled coaching calls with gamified rewards, 2) Scheduled coaching calls with rewards independent of gamification, 3) No scheduled coaching calls with gamified rewards, and 4) No scheduled coaching calls with rewards independent of gamification. The active intervention period will be six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Diagnosis of heart disease, chronic lung disease, or Type 2 diabetes\n* Living with a permanent physical disability (i.e., spina bifida, multiple sclerosis, stroke,)\n* Have the ability to converse in and read English\n* Availability of a smartphone or computer\n\nExclusion Criteria:\n\n* Current enrollment in any structured intervention\n* Severe cognitive impairment\n* Severe untreated depression in the past 6 months\n* Major cardiac event in the past 12 months\n* Uncontrolled blood pressure\n* Resting tachycardia\n* Renal failure\n* Severe peripheral neuropathy\n* Active treatment for cancer in the past 12 months\n* Having both visual and hearing impairments (either of them is fine)'}, 'identificationModule': {'nctId': 'NCT05481593', 'briefTitle': 'An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform: A Pilot Study', 'orgStudyIdInfo': {'id': 'IRB-300009485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scheduled Coaching Calls & Gamified Rewards', 'interventionNames': ['Behavioral: Scheduled Coaching + Gamified Rewards']}, {'type': 'EXPERIMENTAL', 'label': 'No Scheduled Coaching Call & Gamified Rewards', 'interventionNames': ['Behavioral: No Scheduled Coaching Calls + Gamified Rewards']}, {'type': 'EXPERIMENTAL', 'label': 'Scheduled Coaching Calls & Independent rewards (No Gamification)', 'interventionNames': ['Behavioral: Scheduled Coaching Calls + Independent Rewards']}, {'type': 'EXPERIMENTAL', 'label': 'No Scheduled Coaching Calls & Independent Rewards (No Gamification)', 'interventionNames': ['Behavioral: No Scheduled Coaching Calls + Independent rewards']}], 'interventions': [{'name': 'Scheduled Coaching + Gamified Rewards', 'type': 'BEHAVIORAL', 'description': 'Participants will receive scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)', 'armGroupLabels': ['Scheduled Coaching Calls & Gamified Rewards']}, {'name': 'Scheduled Coaching Calls + Independent Rewards', 'type': 'BEHAVIORAL', 'description': 'Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)', 'armGroupLabels': ['Scheduled Coaching Calls & Independent rewards (No Gamification)']}, {'name': 'No Scheduled Coaching Calls + Gamified Rewards', 'type': 'BEHAVIORAL', 'description': 'Participants will not have scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)', 'armGroupLabels': ['No Scheduled Coaching Call & Gamified Rewards']}, {'name': 'No Scheduled Coaching Calls + Independent rewards', 'type': 'BEHAVIORAL', 'description': 'Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)', 'armGroupLabels': ['No Scheduled Coaching Calls & Independent Rewards (No Gamification)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mohanraj Thirumalai', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}