Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT07210593
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-20
First Post:
2025-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
STrong Relationships to Improve DiabEtes Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Sequential Multiple Assignment Randomized Trial (SMART)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': '6 months post-baseline', 'description': 'Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score \\>0) indicate good acceptability'}, {'measure': 'Feasibility (Recruitment)', 'timeFrame': 'baseline', 'description': 'Number of participants screened/week'}, {'measure': 'Feasibility (Recruitment)', 'timeFrame': 'baseline', 'description': 'Proportion of eligible screens who enroll'}, {'measure': 'Feasibility (Treatment Adherence)', 'timeFrame': '6 months post-baseline', 'description': 'Proportion of sessions attended'}, {'measure': 'Feasibility (Treatment Adherence)', 'timeFrame': '6 months post-baseline', 'description': 'Proportion of interactive texts with response'}, {'measure': 'Feasibility (Assessment Completion)', 'timeFrame': '3 and 6 months post-baseline', 'description': 'Proportion of self-report measures completed'}], 'secondaryOutcomes': [{'measure': 'Change in Hemoglobin A1c', 'timeFrame': 'Baseline and 3 and 6 months post-baseline', 'description': 'Hemoglobin A1c assessed by mail-in A1c kits from BioQuintex and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management'}, {'measure': 'Change in Diabetes Distress', 'timeFrame': 'Baseline and 3 and 6 months post-baseline', 'description': 'Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse)'}, {'measure': 'Change in Psychosocial Well-being', 'timeFrame': 'Baseline and 3 and 6 months post-baseline', 'description': 'Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)'}, {'measure': 'Change in Social Support for Diabetes', 'timeFrame': 'Baseline and 3 and 6 months post-baseline', 'description': 'Assessed by the Diabetes Support Scale (DSS) with scores ranging 12 to 84 where higher scores indicate more social support for diabetes (better)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'SMART'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This is a pilot and feasibility study for a mobile phone-delivered intervention, called STRIDE (STrong Relationships to Improve DiabEtes), designed to provide support for adults with type 2 diabetes (improve glycemic management and social support). The goal of the study is to examine the feasibility and acceptability of STRIDE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPERSONS WITH DIABETES:\n\n* Speaks and reads in English\n* 18-75 years old\n* Diagnosed with type 2 diabetes\n* Receiving outpatient care from a partnering clinic\n* Community-dwelling (e.g., not in a nursing facility)\n* Prescribed at least one daily diabetes medication\n* Owns a mobile phone\n* Elevated diabetes distress or low diabetes self-efficacy\n* Willing to invite a close friend or family member to co-participate\n\nSUPPORT PERSONS:\n\n* Speaks and reads in English\n* 18 years or older\n* Owns a mobile phone\n\nExclusion Criteria:\n\nPERSONS WITH DIABETES\n\n* Unable to communicate by phone\n* Currently pregnant\n* Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)\n* Diagnosed with end-stage renal disease\n* Receiving hospice services\n* Diagnosed with congestive heart failure\n* Diagnosed with dementia\n* Diagnosed with schizophrenia\n* Demonstrated an inability to receive and respond to a text\n* Does not take medication on his/her own/medication administered by someone else SUPPORT PERSONS\n* Demonstrated inability to receive \\& respond to a text\n* Unable to communicate by phone'}, 'identificationModule': {'nctId': 'NCT07210593', 'acronym': 'STRIDE', 'briefTitle': 'STrong Relationships to Improve DiabEtes Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'STrong Relationships to Improve DiabEtes (STRIDE) Pilot', 'orgStudyIdInfo': {'id': '250845'}, 'secondaryIdInfos': [{'id': 'K23DK140531', 'link': 'https://reporter.nih.gov/quickSearch/K23DK140531', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Step 1: Optimal First Line Treatment', 'description': 'Persons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support.', 'interventionNames': ['Behavioral: FAMS', 'Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Step 2: Optimal Second Line Treatment', 'description': 'All PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages.', 'interventionNames': ['Behavioral: FAMS', 'Behavioral: PEER']}], 'interventions': [{'name': 'FAMS', 'type': 'BEHAVIORAL', 'description': 'PWD participants will receive FAMS components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment.\n\nCo-enrolled SP participants will receive high-quality print materials upon enrollment and receive text message support tailored to the goal set by the linked PWD.', 'armGroupLabels': ['Experimental: Step 1: Optimal First Line Treatment', 'Experimental: Step 2: Optimal Second Line Treatment']}, {'name': 'PEER', 'type': 'BEHAVIORAL', 'description': 'PWD participants will receive PEER components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment PWD participants assigned to PEER will be matched with another PWD participant assigned to peer to provide peer support to each other.', 'armGroupLabels': ['Experimental: Step 1: Optimal First Line Treatment', 'Experimental: Step 2: Optimal Second Line Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After study results are posted on clinical trials (required to occur within 1 year of final data collection), scientific data will be submitted to the Open Science Framework (OSF). Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.', 'ipdSharing': 'YES', 'description': 'After study results are posted on clinical trials, de-identified individual and aggregate survey, clinical, and laboratory data (including raw and recoded data) and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be made publicly available through the Open Science Framework (OSF).', 'accessCriteria': 'Survey, clinical, and laboratory data and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be shared and made publicly available through OSF as open access. Survey, clinical, and laboratory data will be made available in csv and text format and will not require the use of specialized tools to be accessed or manipulated. All shared data and documentation will be findable and identifiable using the standard data indexing tools in Open Science Framework.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'McKenzie Roddy', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}