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Kidney TransplantNCT07815782

Tailored mHealth Coaching and Social Resource Support in Kidney Transplantation

A study testing mHealth app plus personalized coaching and Social work support in people with Kidney Transplant, run by Duke University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Kidney Transplant
What is being tested?
mHealth app plus personalized coaching and Social work support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
339 participants
Where
1 siteUnited States
Study dates
Feb 2027to Jan 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Cognitive impairment/dementia
  • Active rejection
  • End stage kidney disease
  • Multiple organs transplanted

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lynnette Moats Study Coordinator, MSN contact

919-681-3399

lynnette.moats@duke.edu

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Lynnette Moats, MSN, 919-681-3399, lynnette.moats@duke.edu

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
mHealth app plus personalized coaching, Social work support
Keywords
coaching, kidney transplant app

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth app plus personalized coachingBehavioural

    Participants will download and use the mHealth app to complete surveys and interact with a trained Transplant nurse coach.

  • Social work supportBehavioural

    A trained social worker will provide support to identify resources to help improve transplant outcomes.

Study groups in NCT07815782
Study groupRoleWhat they receive
Usual CareNo interventionNot described
mHealth app plus personalized coachingExperimentalmHealth app plus personalized coaching
Receives: Behavioral: mHealth app plus personalized coaching
mHealth app plus personalized coaching and social worker supportExperimentalNot described
Receives: Behavioral: mHealth app plus personalized coaching; Behavioral: Social work support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (13)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. Change in EHR-documented graft function (eGFR)

    Graft function will be measured by estimated glomerular filtration rate (eGFR).

    Measured: 6 months

  7. Change in EHR-documented graft function (biopsy-proven rejection)

    Graft function will be measured by incidence of biopsy-proven rejection.

    Measured: 6 months

  8. Change in EHR-documented graft function (hospital admissions)

    Graft function will be measured by incidence of hospital admissions.

    Measured: 6 months

  9. Change in EHR-documented graft function (graft loss)

    Graft function will be measured by incidence of graft loss.

    Measured: 6 months

  10. Change in EHR-documented graft function (death)

    Graft function will be measured by incidence of death.

    Measured: 6 months

  11. 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.

    Measured: 6 months

  12. Number of participants who complete an interview related to assess facilitators and barriers for future large-scale implementation

    Measured: 6 months

  13. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study startFeb 2027 (estimated)
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
339 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07815782
Sponsor's protocol ID
Pro00120486
Other IDs
1R01MD020306-01
Status last verified
Aug 2026
First submitted
14 Aug 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 27286686

  • 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.

    PubMed 11392867

  • 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.

    PubMed 37701558

  • 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.

    PubMed 36935874

Questions about this trial

What is this clinical trial studying?

A study testing mHealth app plus personalized coaching and Social work support in people with Kidney Transplant, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lynnette Moats Study Coordinator, MSN (919-681-3399, lynnette.moats@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient Activation Measure (PAM) from baseline to 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07815782, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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