Kidney Transplant
Conditions
Keywords
coaching, kidney transplant app
Brief 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. 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.
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.
Interventions
BEHAVIORALmHealth app plus personalized coaching
Participants will download and use the mHealth app to complete surveys and interact with a trained Transplant nurse coach.
BEHAVIORALSocial work support
A trained social worker will provide support to identify resources to help improve transplant outcomes.
Sponsors
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Activation Measure (PAM) from baseline to 6 months | 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 | 6 months | Blood pressure control defined as absence of hypertension \>130/80 mmhg at the end of 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in patient reported self-management using Partners in Health. | 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 | 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) | 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) | 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. | 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) | 6 months | Graft function will be measured by estimated glomerular filtration rate (eGFR). |
| Change in EHR-documented graft function (biopsy-proven rejection) | 6 months | Graft function will be measured by incidence of biopsy-proven rejection. |
| Change in EHR-documented graft function (hospital admissions) | 6 months | Graft function will be measured by incidence of hospital admissions. |
| Change in EHR-documented graft function (graft loss) | 6 months | Graft function will be measured by incidence of graft loss. |
| Change in EHR-documented graft function (death) | 6 months | Graft function will be measured by incidence of death. |
| Change in EHR-documented biomarkers of post-transplant management | 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 | 6 months | — |
| Percent of participants who report a positive experience with the intervention | 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 |
Countries
United States
Contacts
CONTACTLynnette Moats Study Coordinator, MSN
PRINCIPAL_INVESTIGATOREileen Chambers, MD
Duke University
Outcome results
None listed