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Transplantatie begeleiding op maat

promoting Medication AdheRence and Self-management among kidney transplant recipients: a randomized controlled trial (the MARS Trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21249
Enrollment
162
Registered
2018-09-07
Start date
2018-09-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation, adherence, self-management, health psychology Niertransplantatie, therapietrouw, zelfmanagement, medische psychologie

Interventions

During the study the experimental group will receive an outreaching, systemic (involving family & social network), tailored intervention to promote medication adherence and self-management after trans

Sponsors

Performer: Erasmus MC, University Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Functioning kidney transplant - Aged 12 years and above (no upper limit is set) - Report of nonadherence (to immunosuppressive medication) by either the patient (self-report), the health care professional (collateral report) or an important person from the social network of the patient (collateral report)

Exclusion criteria

Exclusion criteria: - Patients who are not classified as non-adherent to the immunosuppressive medication - Patients on dialysis at the start of the intervention - Insufficient level of speaking and understanding Dutch language to complete the questionnaires - pre-transplant patients

Design outcomes

Primary

MeasureTime frame
The primary outcome of this RCT is adherence to the immunosuppressive medication (IM) regimen as measured with electronic monitoring.

Secondary

MeasureTime frame
The secondary outcomes of the intervention are: - Adherence to the IM regimen as measured with a composite adherence score - Medical outcomes such as intra patient variability, rejection, kidney functioning, and hospitalisations - Psychosocial outcomes for the patient, such as self-managament skills, quality of life, self-efficacy, mental health and social support. - Psychosocial outcomes for important other in the social network of the patient, such as mental health, quality of life, and social support.

Contacts

Public ContactE.K. Massey

Erasmus MC Postbus 2040

e.massey@erasmusmc.nl+31 (0)10 7033451

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)