Tailored mHealth Coaching and Social Resource Support in Kidney Transplantation
2 other identifiers
interventional
339
1 country
1
Brief Summary
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. Participants 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2026
CompletedFirst Posted
Study publicly available on registry
September 11, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
Study Completion
Last participant's last visit for all outcomes
January 1, 2031
September 11, 2026
August 1, 2026
2.9 years
August 14, 2026
September 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Change in blood pressure control at 6 months
Blood pressure control defined as absence of hypertension \>130/80 mmhg at the end of 6 months.
6 months
Secondary Outcomes (13)
Change from baseline in patient reported self-management using Partners in Health.
6 months
Change in medication adherence using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) survey
6 months
Change in patient-clinician communication as measured by the Perceived Involvement in Care Scale (PICS)
6 months
Change in health-related quality of life using the Kidney Transplant Questionnaire (KTQ-25)
6 months
Change in nutritional behaviors assessed using the Nutrition Self-Efficacy Scale.
6 months
- +8 more secondary outcomes
Study Arms (3)
Usual Care
NO INTERVENTIONmHealth app plus personalized coaching
EXPERIMENTALmHealth app plus personalized coaching
mHealth app plus personalized coaching and social worker support
EXPERIMENTALInterventions
Participants will download and use the mHealth app to complete surveys and interact with a trained Transplant nurse coach.
A trained social worker will provide support to identify resources to help improve transplant outcomes.
Eligibility Criteria
You may qualify if:
- Residence in a neighborhood with medium to high SVI score.
- Age 18 to 65
- Stable allograft function at minimum 1 month post-transplantation
- Ability to communicate proficiently in English
- On sirolimus and/or tacrolimus-based immunosuppression
You may not qualify if:
- Cognitive impairment/dementia
- Active rejection
- End stage kidney disease
- Multiple organs transplanted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (5)
Deci EL, Ryan RM. Self-Determination Theory: A Macrotheory of Human Motivation, Development, and Health: Canadian Psychology / Psychologie Canadienne. Can Psychol Psychol Can. 2008;49(3):182-185. doi:10.1037/a0012801
BACKGROUNDPizzo HP, Ettenger RB, Gjertson DW, Reed EF, Zhang J, Gritsch HA, Tsai EW. Sirolimus and tacrolimus coefficient of variation is associated with rejection, donor-specific antibodies, and nonadherence. Pediatr Nephrol. 2016 Dec;31(12):2345-2352. doi: 10.1007/s00467-016-3422-5. Epub 2016 Jun 10.
PMID: 27286686BACKGROUNDRyan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
PMID: 11392867BACKGROUNDPollock MD, Brotkin SM, Denio E, Dave S, Fisher EB, Docherty SL, Maslow GR. Clinical Application of a Peer Coaching Intervention to Enhance Self-Management for Adolescents and Young Adults With Inflammatory Bowel Disease. Clin Pract Pediatr Psychol. 2022 Dec;10(4):409-427. doi: 10.1037/cpp0000468.
PMID: 37701558BACKGROUNDPollock MD, Stauffer N, Lee HJ, Chow SC, Satoru I, Moats L, Swan-Nesbit S, Li Y, Roberts JK, Ellis MJ, Diamantidis CJ, Docherty SL, Chambers ET. MyKidneyCoach, Patient Activation, and Clinical Outcomes in Diverse Kidney Transplant Recipients: A Randomized Control Pilot Trial. Transplant Direct. 2023 Mar 15;9(4):e1462. doi: 10.1097/TXD.0000000000001462. eCollection 2023 Apr.
PMID: 36935874BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen Chambers, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2026
First Posted
September 11, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2031
Last Updated
September 11, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share