Motivational Interviewing for Adult Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

— MIAKTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956406
• Other study ID #: 0000
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: July 2022

Study information

• Verified date: March 2022
• Source: Akdeniz University
• Contact: Çigdem Erdem, MSc
• Phone: +905075011397
• Email: cgdmctn07[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Glomerular Filtration Rate (GFR)	official measurements made by the hospital	Change from Baseline GFR at 3 months
Secondary	Serum Creatinine	official measurements made by the hospital	Change from Baseline Serum Creatinine at 3 months