CClinicalTrials.gg
Status unknownNCT04956406MIAKTRUpdated Mar 31, 2022

Motivational Interviewing for Adult Kidney Transplant Recipients

An interventional study of Motivational Interviewing for Adult Kidney Transplant Recipients and Routine care in Motivational Interviewing, Adult and Kidney Transplantation, sponsored by Akdeniz University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Akdeniz University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2021, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Motivational Interviewing
  • Recipient
  • Kidney Transplantation
  • Self-Management
03

In context

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Request to leave work

Removing Criteria:

  • Development of rejection
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    MIAKTR

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

    Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients

  • Active comparator
    Control Group

    routine care

    Other: Routine care

Interventions

  • BehavioralMotivational 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

  • OtherRoutine 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline Self Management at 3 months

  2. 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

    Time frame: Change from Baseline VAS for Medication Adherence at 3 months

  3. 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".

    Time frame: Change from Baseline VAS for self care at 3 months

Secondary outcomes

  1. Glomerular Filtration Rate (GFR)

    official measurements made by the hospital

    Time frame: Change from Baseline GFR at 3 months

  2. Serum Creatinine

    official measurements made by the hospital

    Time frame: Change from Baseline Serum Creatinine at 3 months

07

Study locations

1 of 1 sites recruiting
  • Akdeniz University
    Antalya, Turkey
    • Çiğdem Erdem · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04956406
Lead sponsor
Akdeniz University
Responsible party
Cigdem Erdem (Research Asistant, Akdeniz University) — Principal investigator
First posted
Jul 9, 2021
Start date
Jan 4, 2021
Primary completion
Mar 2022 (estimated)
Completion
Jul 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Çiğdem Erdem, MSc
Contact
cgdmctn07@gmail.com
+905075011397
Fatma Cebeci, PhD
Contact
fatmacebeci@gmail.com
+905366137926

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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