[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655577":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":62,"studyPopulation":52,"armGroups":63,"interventions":76,"overallOfficials":85,"centralContacts":89,"locations":95,"responsibleParty":112,"collaborators":114,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":52,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":52,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":140,"whyStopped":52,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":52},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Patient Activation Measure (PAM) from baseline to 6 months","The PAM is a 13-item scale (score range 0-100) of patient activation in healthcare. Higher scores indicate more patient activation.","6 months",{"measure":14,"description":15,"timeFrame":12},"Change in blood pressure control at 6 months","Blood pressure control defined as absence of hypertension \\>130\u002F80 mmhg at the end of 6 months.",[17,20,23,26,29,32,35,38,41,44,47,50,53],{"measure":18,"description":19,"timeFrame":12},"Change from baseline in patient reported self-management using Partners in Health.","Partners in Health is a 12-item scale with a score-range 0-96. Higher scores means better chronic condition self-management.",{"measure":21,"description":22,"timeFrame":12},"Change in medication adherence using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) survey","The BAASIS survey is a 4-item questionnaire (score-range 0-120) used to measure how transplant patients take their prescribed anti-rejection drugs. Higher score means higher levels of medication nonadherence.",{"measure":24,"description":25,"timeFrame":12},"Change in patient-clinician communication as measured by the Perceived Involvement in Care Scale (PICS)","The PICS is a 13-item measure with a score range of 0-13. Higher scores indicate more patient involvement in medical decision and interactions with health providers",{"measure":27,"description":28,"timeFrame":12},"Change in health-related quality of life using the Kidney Transplant Questionnaire (KTQ-25)","The KTQ-25 is a 25-item survey to assess the quality of life of kidney transplant recipients. Higher score indicates better quality of life and experiences minimal disruption from kidney disease.",{"measure":30,"description":31,"timeFrame":12},"Change in nutritional behaviors assessed using the Nutrition Self-Efficacy Scale.","The Nutrition Self-Efficacy Scale is a 20-item measure, with a score-range 0-100. Higher scores indicate more confidence in the ability to maintain a healthy diet.",{"measure":33,"description":34,"timeFrame":12},"Change in EHR-documented graft function (eGFR)","Graft function will be measured by estimated glomerular filtration rate (eGFR).",{"measure":36,"description":37,"timeFrame":12},"Change in EHR-documented graft function (biopsy-proven rejection)","Graft function will be measured by incidence of biopsy-proven rejection.",{"measure":39,"description":40,"timeFrame":12},"Change in EHR-documented graft function (hospital admissions)","Graft function will be measured by incidence of hospital admissions.",{"measure":42,"description":43,"timeFrame":12},"Change in EHR-documented graft function (graft loss)","Graft function will be measured by incidence of graft loss.",{"measure":45,"description":46,"timeFrame":12},"Change in EHR-documented graft function (death)","Graft function will be measured by incidence of death.",{"measure":48,"description":49,"timeFrame":12},"Change in EHR-documented biomarkers of post-transplant management","Donor-specific antibodies and variation in immunosuppressant levels are objective measurements that will be collected as part of participants' standard of care labs. They reflect good or poor post-transplant management.",{"measure":51,"description":52,"timeFrame":12},"Number of participants who complete an interview related to assess facilitators and barriers for future large-scale implementation",null,{"measure":54,"description":55,"timeFrame":12},"Percent of participants who report a positive experience with the intervention","Percent of participants (intervention participants and kidney transplant clinicians) who report a positive experience with the intervention as measure on a likert scale of 1-5 with higher scores indicating higher satisfaction with the intervention",{"allocation":57,"interventionModel":58,"interventionModelDescription":52,"primaryPurpose":59,"observationalModel":52,"timePerspective":52,"maskingInfo":60},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":61,"maskingDescription":52,"whoMasked":52},"NONE","Participants in this study will randomized to one of 3 groups: usual care, use of mHealth app with personalized coaching, or use of mHealth app with personalized coaching plus a dedicated social worker. Participants assigned to use the mHealth app will be required to download the app to their phone. All participants will complete surveys about their experience and symptoms at study enrollment then at 3 months and 6 months after study enrollment. Some participants may also be asked to participate in a semi-structured interview after the 6-month visit. Participants will be monitored to determine if the mHealth app will improve patient activation and kidney transplant outcomes.",[64,67,72],{"label":65,"type":66,"description":52,"interventionNames":52},"Usual Care","NO_INTERVENTION",{"label":68,"type":69,"description":68,"interventionNames":70},"mHealth app plus personalized coaching","EXPERIMENTAL",[71],"Behavioral: mHealth app plus personalized coaching",{"label":73,"type":69,"description":52,"interventionNames":74},"mHealth app plus personalized coaching and social worker support",[71,75],"Behavioral: Social work support",[77,81],{"type":78,"name":68,"description":79,"armGroupLabels":80,"otherNames":52},"BEHAVIORAL","Participants will download and use the mHealth app to complete surveys and interact with a trained Transplant nurse coach.",[68,73],{"type":78,"name":82,"description":83,"armGroupLabels":84,"otherNames":52},"Social work support","A trained social worker will provide support to identify resources to help improve transplant outcomes.",[73],[86],{"name":87,"affiliation":5,"role":88},"Eileen Chambers, MD","PRINCIPAL_INVESTIGATOR",[90],{"name":91,"role":92,"phone":93,"phoneExt":52,"email":94},"Lynnette Moats Study Coordinator, MSN","CONTACT","919-681-3399","lynnette.moats@duke.edu",[96],{"facility":97,"status":52,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Duke University Medical Center","Durham","North Carolina","27710","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-78.89862,35.99403,{"lat":107,"lon":106},[110],{"name":111,"role":92,"phone":93,"phoneExt":52,"email":94},"Lynnette Moats, MSN",{"type":113,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[115],{"name":116,"class":117},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100655577","tailored-mhealth-coaching-and-social-resource-support-in-kidney-transplantation-100655577",false,"NCT07815782","Tailored mHealth Coaching and Social Resource Support in Kidney Transplantation","Tailored mHealth Coaching and Social Resource Support to Reduce Health Disparities in Kidney Transplantation","Inclusion Criteria:\n\n* Residence in a neighborhood with medium to high SVI score.\n* Age 18 to 65\n* Stable allograft function at minimum 1 month post-transplantation\n* Ability to communicate proficiently in English\n* On sirolimus and\u002For tacrolimus-based immunosuppression\n\nExclusion Criteria:\n\n* Cognitive impairment\u002Fdementia\n* Active rejection\n* End stage kidney disease\n* Multiple organs transplanted","ALL","18 Years","65 Years",{"count":129,"type":130},339,"ESTIMATED","INTERVENTIONAL",[133],"NA","The purpose of this study is to learn if a mobile app, personalized coaching, and assistance from social workers can help improve outcomes for kidney transplant patients.\n\nParticipants in this study will be randomized to one of 3 groups: usual care, use of mHealth app, or use of mHealth plus a dedicated social worker. Participants assigned to use the mHealth app will be required to download the app to their phone. All participants will complete surveys about their experience and symptoms at study enrollment then at 3 months and 6 months after study enrollment. Some participants may also be asked to participate in a semi-structured interview after the 6-month visit.",[136],"Kidney Transplant",[138,139],"coaching","kidney transplant app","NOT_YET_RECRUITING","2026-09-08",{"date":143,"type":144},"2026-09-11","ACTUAL",{"date":146,"type":130},"2027-02",{"date":148,"type":130},"2031-01",{"name":5,"class":6},1]