Tailored mHealth Coaching and Social Resource Support in Kidney Transplantation

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07815782
Status
Not Yet Recruiting

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Conditions

  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • mHealth app plus personalized coaching — BEHAVIORAL
    Participants will download and use the mHealth app to complete surveys and interact with a trained Transplant nurse coach.
  • Social work support — BEHAVIORAL
    A trained social worker will provide support to identify resources to help improve transplant outcomes.

Study Details

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.

Key Dates

First listed
Sep 11, 2026
Start date
Feb 28, 2027
Status verified
Aug 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
339 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care
  • Experimental: mHealth app plus personalized coaching
    mHealth app plus personalized coaching
  • Experimental: mHealth app plus personalized coaching and social worker support

Primary Outcome Measure

Change in Patient Activation Measure (PAM) from baseline to 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Lynnette Moats, MSN
919-681-3399

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