Skip to main content
Clinical Trials/NCT04956406
NCT04956406
Unknown
Not Applicable

The Effect of Motivational Interviewing on Self-Management in Adult Kidney Transplant Recipients Versus Routine Care

Akdeniz University1 site in 1 country80 target enrollmentJanuary 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Motivational Interviewing
Sponsor
Akdeniz University
Enrollment
80
Locations
1
Primary Endpoint
Self-management scale
Last Updated
4 years ago

Overview

Brief Summary

Purpose: This study aimed to determine the effect of motivational interviewing on self-management of treatment regimen, medication adherence, and patient outcomes in adult kidney transplant recipients between 3 months and 6 months after kidney transplant in the transplant outpatient clinic.

Design: The research is a single-centered, single-blind, parallel and 1:1 randomized active comparative experimental study.

Method: A total of 80 individuals, of the 40 in the control group and 40 in the intervention group, will be included in the study. Motivational interview sessions for the intervention group will be held 3 times between 15-30 minutes with an interval of 10 days. The control group will be given routine care (approximately 1 hour of face-to-face standard training) by the nurse educator. Within the research pattern, intervention and control groups will be applied pre-test at the first interview and post test after one month. In addition, follow-up test will be performed 3th month. The data will be obtained using the Self-Management Scale in Kidney Transplant Recipients, Visual Analog Scale (VAS) for self-care and VAS for medication adherence. In the study, Standard Protocol Items: Recommendations for Interventional Trials- SPIRIT(2013) and CONSORT 2010 (Consolidated Standards of Reporting Trials) were used.

Registry
clinicaltrials.gov
Start Date
January 4, 2021
End Date
July 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cigdem Erdem

Research Asistant

Akdeniz University

Eligibility Criteria

Inclusion Criteria

  • Volunteering to participate in the study,
  • aged ≥18 years old
  • 3-6 months after kidney transplant
  • Speaking, reading and writing in Turkish
  • Having a mobile phone

Exclusion Criteria

  • Request to leave work
  • Removing Criteria:
  • Development of rejection

Outcomes

Primary Outcomes

Self-management scale

Time Frame: Change from Baseline Self Management at 3 months

The scale Turkish version includes 13 items, and it is likert type with 4 steps. Scale items are scored as 1 "never applied", 2 "applied slightly", 3 "applied very often" and 4 "fully applied". It is recommended to perform calculation based on the item mean scores instead of an overall mean. The lowest possible score obtained from each item and sub-scale is 1 and the highest possible score is 4. The scale has no cutoff points and reversed items.

VAS for medication adherence

Time Frame: Change from Baseline VAS for Medication Adherence at 3 months

Medication adherence will be evaluated with self reported scale the visual analog scale ranges from 0 to 100. Rating will be of 0 "taken no medications" to 100 "taken medications perfectly". A score different from 100 will be considered a non adherence

VAS for self care

Time Frame: Change from Baseline VAS for self care at 3 months

The rating will be done as 0-100. 0: "I cannot provide my own care".100:"I am able to provide my own care".

Secondary Outcomes

  • Serum Creatinine(Change from Baseline Serum Creatinine at 3 months)
  • Glomerular Filtration Rate (GFR)(Change from Baseline GFR at 3 months)

Study Sites (1)

Loading locations...

Similar Trials