[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07210593":3,"trial-entities:NCT07210593":120,"trial-summary:NCT07210593":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":62,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":104,"locations":107,"central_contacts":116,"overall_officials":117,"references":118,"see_also_links":119},"NCT07210593","250845","STrong Relationships to Improve DiabEtes Pilot","STrong Relationships to Improve DiabEtes (STRIDE) Pilot","ENROLLING_BY_INVITATION","2027-02","2025-10","2025-10-20","2025-10-15","Vanderbilt University Medical Center","OTHER",false,"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.",null,[19],"Type 2 Diabetes",[21,22],"type 2 diabetes","SMART","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},180,"ESTIMATED",[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","FAMS","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.",[36,37],"Experimental: Step 1: Optimal First Line Treatment","Experimental: Step 2: Optimal Second Line Treatment",{"type":32,"name":39,"description":40,"armGroupLabels":41},"PEER","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.",[36,37],[43,47,51,53,56,58],{"measure":44,"description":45,"timeFrame":46},"Acceptability","Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score \\>0) indicate good acceptability","6 months post-baseline",{"measure":48,"description":49,"timeFrame":50},"Feasibility (Recruitment)","Number of participants screened\u002Fweek","baseline",{"measure":48,"description":52,"timeFrame":50},"Proportion of eligible screens who enroll",{"measure":54,"description":55,"timeFrame":46},"Feasibility (Treatment Adherence)","Proportion of sessions attended",{"measure":54,"description":57,"timeFrame":46},"Proportion of interactive texts with response",{"measure":59,"description":60,"timeFrame":61},"Feasibility (Assessment Completion)","Proportion of self-report measures completed","3 and 6 months post-baseline",[63,67,70,73],{"measure":64,"description":65,"timeFrame":66},"Change in Hemoglobin A1c","Hemoglobin A1c assessed by mail-in A1c kits from BioQuintex and\u002For taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management","Baseline and 3 and 6 months post-baseline",{"measure":68,"description":69,"timeFrame":66},"Change in Diabetes Distress","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":71,"description":72,"timeFrame":66},"Change in Psychosocial Well-being","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":74,"description":75,"timeFrame":66},"Change in Social Support for Diabetes","Assessed by the Diabetes Support Scale (DSS) with scores ranging 12 to 84 where higher scores indicate more social support for diabetes (better)","ALL","18 Years","75 Years",{"inclusion":80,"exclusion":91,"raw_text":103},[81,82,83,84,85,86,87,88,89,81,90,87],"Speaks and reads in English","18-75 years old","Diagnosed with type 2 diabetes","Receiving outpatient care from a partnering clinic","Community-dwelling (e.g., not in a nursing facility)","Prescribed at least one daily diabetes medication","Owns a mobile phone","Elevated diabetes distress or low diabetes self-efficacy","Willing to invite a close friend or family member to co-participate","18 years or older",[92,93,94,95,96,97,98,99,100,101,102,92],"Unable to communicate by phone","Currently pregnant","Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)","Diagnosed with end-stage renal disease","Receiving hospice services","Diagnosed with congestive heart failure","Diagnosed with dementia","Diagnosed with schizophrenia","Demonstrated an inability to receive and respond to a text","Does not take medication on his\u002Fher own\u002Fmedication administered by someone else SUPPORT PERSONS","Demonstrated inability to receive \\& respond to a text","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\u002Fher own\u002Fmedication administered by someone else SUPPORT PERSONS\n* Demonstrated inability to receive \\& respond to a text\n* Unable to communicate by phone",[105,106],"ADULT","OLDER_ADULT",[108],{"facility":13,"city":109,"state":110,"zip":111,"country":112,"geoPoint":113},"Nashville","Tennessee","37203","United States",{"lat":114,"lon":115},36.16589,-86.78444,[],[],[],[],{"nct_id":4,"conditions":121,"biomarkers":123},[122],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]