Duke University Medical Center
Durham, North Carolina, 27710, United States
Not yet recruiting
NCT Number: NCT07815782
Tailored mHealth Coaching and Social Resource Support 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.
Not yet recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
mHealth app plus personalized coaching
BehavioralParticipants will download and use the mHealth app to complete surveys and interact with a trained Transplant nurse coach.
Social work support
BehavioralA trained social worker will provide support to identify resources to help improve transplant outcomes.
Primary outcomes
-
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.
-
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.
Secondary outcomes
-
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.
-
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.
-
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
-
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.
-
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.
-
Change in EHR-documented graft function (eGFR)
Time frame: 6 months
Graft function will be measured by estimated glomerular filtration rate (eGFR).
-
Change in EHR-documented graft function (biopsy-proven rejection)
Time frame: 6 months
Graft function will be measured by incidence of biopsy-proven rejection.
-
Change in EHR-documented graft function (hospital admissions)
Time frame: 6 months
Graft function will be measured by incidence of hospital admissions.
-
Change in EHR-documented graft function (graft loss)
Time frame: 6 months
Graft function will be measured by incidence of graft loss.
-
Change in EHR-documented graft function (death)
Time frame: 6 months
Graft function will be measured by incidence of death.
-
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.
-
Number of participants who complete an interview related to assess facilitators and barriers for future large-scale implementation
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Duke University
Other
Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
Registry information
Official study title
Tailored mHealth Coaching and Social Resource Support to Reduce Health Disparities in Kidney Transplantation
Important dates
- Study start
- 2027
- Primary completion
- 2030
- Study completion
- 2031
- First posted
- Sep 11, 2026
- Registry last updated
- Sep 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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