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Tailored mHealth Coaching and Social Resource Support in Kidney Transplantation

ConditionKidney Transplant
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Cognitive impairment/dementia

Active rejection

End stage kidney disease

Multiple organs transplanted

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

339 Participants
are divided into 3 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: mHealth app plus personalized coachingExperimental treatment 1 intervention
Group C: mHealth app plus personalized coaching and social worker supportExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
6 months

Secondary outcomes

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.

Time frame
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.

Time frame
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

Time frame
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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: