Motivational Interviewing for Adult Kidney Transplant Recipients (MIAKTR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Medication Adherence; Kidney Transplantation; Treatment Adherence; Motivational Interviewing; Patient Outcome Assessment; Self-Management; Adult
• Intervention / Treatment: Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients; Other: Routine care

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Çiğdem Erdem, MSc; Phone Number: +905075011397; Email: cgdmctn07@gmail.com
• Study Contact Backup: Name: Fatma Cebeci, PhD; Phone Number: +905366137926; Email: fatmacebeci@gmail.com

Study Locations

• Turkey
  • Antalya, Turkey
    • Recruiting
    • Akdeniz University
    • Contact: Çiğdem Erdem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIAKTR; MIAKTR is an acronym that defines Motivational Interviewing for Adult Kidney Transplant Recipients	Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients; Motivational interviewing with individual sessions are planned to be conducted 3 times. Planned motivational interviews will be implemented the intervention group who are within 3th month, 4th month, 5th month and 6th month. Motivational interviewing will planned last 15-30 minutes with an interval of 10 days. The first interview will be performed face-to-face at the transplant outpatient clinic and the second and third ones will be phone interviews
Active Comparator: Control Group; routine care	Other: Routine care; The control group will be provided with routine care( face-to-face care standard training) by the nurse educator at the transplant outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-management scale	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.	Change from Baseline Self Management at 3 months
VAS for medication adherence	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	Change from Baseline VAS for Medication Adherence at 3 months
VAS for self care	The rating will be done as 0-100. 0: "I cannot provide my own care".100:"I am able to provide my own care".	Change from Baseline VAS for self care at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular Filtration Rate (GFR)	official measurements made by the hospital	Change from Baseline GFR at 3 months
Serum Creatinine	official measurements made by the hospital	Change from Baseline Serum Creatinine at 3 months

Collaborators and Investigators

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Self-Management; Kidney Transplantation; Recipient
• Other Study ID Numbers: 0000 (Centre for care Science, KI, Norrbacka Eugeniastiftelsen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No