Motivational Interviewing for Adult Kidney Transplant Recipients

NCT04956406 | Unknown

• 1 other identifier: 0000
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Motivational Interviewing; Adult; Kidney Transplantation; Self-Management; Treatment Adherence; Medication Adherence; Patient Outcome Assessment

Keywords

Motivational Interviewing; Recipient; Kidney Transplantation; Self-Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Glomerular Filtration Rate (GFR)

  Change from Baseline GFR at 3 months

• Serum Creatinine

  Change from Baseline Serum Creatinine at 3 months

Study Arms (2)

MIAKTR

EXPERIMENTAL

MIAKTR is an acronym that defines Motivational Interviewing for Adult Kidney Transplant Recipients

Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients

Control Group

ACTIVE COMPARATOR

routine care

Other: Routine care

Interventions

Motivational Interviewing for Adult Kidney Transplant Recipients BEHAVIORAL

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

MIAKTR

Routine care OTHER

The control group will be provided with routine care( face-to-face care standard training) by the nurse educator at the transplant outpatient clinic.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Treatment Adherence and Compliance; Medication Adherence

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Çiğdem Erdem, MSc

CONTACT

+905075011397; cgdmctn07@gmail.com

Fatma Cebeci, PhD

CONTACT

+905366137926; fatmacebeci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The statistician will be blinded to avoid evaluator bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 9, 2021
• Study Start: January 4, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)