Motivational Interviewing for Adult Kidney Transplant Recipients

Study Overview
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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.

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

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

Intervention / Treatment
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* Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients
* Other: Routine care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIAKTR<br>MIAKTR is an acronym that defines Motivational Interviewing for Adult Kidney Transplant Recipients | Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients<br>* 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<br>|
| Active Comparator: Control Group<br>routine care | Other: Routine care<br>* The control group will be provided with routine care( face-to-face care standard training) by the nurse educator at the transplant outpatient clinic.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational Interviewing, Recipient, Kidney Transplantation, Self-Management