Motivational Interviewing for Adult Kidney Transplant Recipients

NCT ID: NCT04956406

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The statistician will be blinded to avoid evaluator bias.

Study Groups

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MIAKTR

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

Group Type EXPERIMENTAL

Motivational Interviewing for Adult Kidney Transplant Recipients

Intervention Type 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

Control Group

routine care

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type 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.

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Cigdem Erdem

Research Asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Çiğdem Erdem, MSc

Role: CONTACT

+905075011397

Fatma Cebeci, PhD

Role: CONTACT

+905366137926

Facility Contacts

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Çiğdem Erdem

Role: primary

Other Identifiers

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0000

Identifier Type: -

Identifier Source: org_study_id

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