MIAKTR: Motivational Interviewing for Adult Kidney Transplant Recipients

Sponsor
Akdeniz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04956406
Collaborator
(none)
80
1
2
17.8
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients
  • Other: Routine care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
The statistician will be blinded to avoid evaluator bias.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Motivational Interviewing on Self-Management in Adult Kidney Transplant Recipients Versus Routine Care
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Self-management scale [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.

  2. VAS for medication adherence [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

  3. VAS for self care [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 Outcome Measures

  1. Glomerular Filtration Rate (GFR) [Change from Baseline GFR at 3 months]

    official measurements made by the hospital

  2. Serum Creatinine [Change from Baseline Serum Creatinine at 3 months]

    official measurements made by the hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akdeniz University Antalya Turkey

Sponsors and Collaborators

  • Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cigdem Erdem, Research Asistant, Akdeniz University
ClinicalTrials.gov Identifier:
NCT04956406
Other Study ID Numbers:
  • 0000
First Posted:
Jul 9, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cigdem Erdem, Research Asistant, Akdeniz University

Study Results

No Results Posted as of Mar 31, 2022