Tailored mHealth Coaching and Social Resource Support in Kidney Transplantation
September 8, 2026 updated by: Duke University
Tailored mHealth Coaching and Social Resource Support to Reduce Health Disparities in Kidney Transplantation
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
339
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lynnette Moats Study Coordinator, MSN
- Phone Number: 919-681-3399
- Email: lynnette.moats@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
Contact:
- Lynnette Moats, MSN
- Phone Number: 919-681-3399
- Email: lynnette.moats@duke.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cognitive impairment/dementia
- Active rejection
- End stage kidney disease
- Multiple organs transplanted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
|
|
|
Experimental: mHealth app plus personalized coaching
|
Participants will download and use the mHealth app to complete surveys and interact with a trained Transplant nurse coach.
|
|
Experimental: mHealth app plus personalized coaching and social worker support
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient Activation Measure (PAM) from baseline to 6 months
Time Frame: 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
Time Frame: 6 months
|
Blood pressure control defined as absence of hypertension >130/80 mmhg at the end of 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in patient reported self-management using Partners in Health.
Time Frame: 6 months
|
Partners in Health is a 12-item scale with a score-range 0-96.
Higher scores means better chronic condition self-management.
|
6 months
|
|
Change in medication adherence using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) survey
Time Frame: 6 months
|
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.
|
6 months
|
|
Change in patient-clinician communication as measured by the Perceived Involvement in Care Scale (PICS)
Time Frame: 6 months
|
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
|
6 months
|
|
Change in health-related quality of life using the Kidney Transplant Questionnaire (KTQ-25)
Time Frame: 6 months
|
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.
|
6 months
|
|
Change in nutritional behaviors assessed using the Nutrition Self-Efficacy Scale.
Time Frame: 6 months
|
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.
|
6 months
|
|
Change in EHR-documented graft function (eGFR)
Time Frame: 6 months
|
Graft function will be measured by estimated glomerular filtration rate (eGFR).
|
6 months
|
|
Change in EHR-documented graft function (biopsy-proven rejection)
Time Frame: 6 months
|
Graft function will be measured by incidence of biopsy-proven rejection.
|
6 months
|
|
Change in EHR-documented graft function (hospital admissions)
Time Frame: 6 months
|
Graft function will be measured by incidence of hospital admissions.
|
6 months
|
|
Change in EHR-documented graft function (graft loss)
Time Frame: 6 months
|
Graft function will be measured by incidence of graft loss.
|
6 months
|
|
Change in EHR-documented graft function (death)
Time Frame: 6 months
|
Graft function will be measured by incidence of death.
|
6 months
|
|
Change in EHR-documented biomarkers of post-transplant management
Time Frame: 6 months
|
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.
|
6 months
|
|
Number of participants who complete an interview related to assess facilitators and barriers for future large-scale implementation
Time Frame: 6 months
|
6 months
|
|
|
Percent of participants who report a positive experience with the intervention
Time Frame: 6 months
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eileen Chambers, MD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ryan 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.
- Pizzo 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.
- 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
- Pollock 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.
- Pollock 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2031
Study Registration Dates
First Submitted
August 14, 2026
First Submitted That Met QC Criteria
September 8, 2026
First Posted (Actual)
September 11, 2026
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 8, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00120486
- 1R01MD020306-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.