Motivational InterviewingMIAKTRNCT04956406
Motivational Interviewing for Adult Kidney Transplant Recipients
A study testing Motivational Interviewing for Adult Kidney Transplant Recipients and Routine care in people with Motivational Interviewing and Adult, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing, Adult, Kidney Transplantation
- What is being tested?
- Motivational Interviewing for Adult Kidney Transplant Recipients and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Request to leave work
- Removing Criteria:
- Development of rejection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya
Çiğdem Erdem
About this study
Official title: The Effect of Motivational Interviewing on Self-Management in Adult Kidney Transplant Recipients Versus Routine Care
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
- Being tested
- Motivational Interviewing for Adult Kidney Transplant Recipients, Routine care
- Keywords
- Motivational Interviewing, Recipient, Kidney Transplantation, Self-Management
- Medical subject headings
- Treatment Adherence and Compliance, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing for Adult Kidney Transplant RecipientsBehavioural
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
Routine careOther
The control group will be provided with routine care( face-to-face care standard training) by the nurse educator at the transplant outpatient clinic.
| Study group | Role | What they receive |
|---|---|---|
| MIAKTR | Experimental | MIAKTR is an acronym that defines Motivational Interviewing for Adult Kidney Transplant Recipients Receives: Behavioral: Motivational Interviewing for Adult Kidney Transplant Recipients |
| Control Group | Active comparator | routine care Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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".
Measured: Change from Baseline VAS for self care at 3 months
Secondary outcomes (2)
Glomerular Filtration Rate (GFR)
official measurements made by the hospital
Measured: Change from Baseline GFR at 3 months
Serum Creatinine
official measurements made by the hospital
Measured: Change from Baseline Serum Creatinine at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start4 Jan 2021
- Primary completionMar 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Erdem, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956406
- Sponsor's protocol ID
- 0000
- Acronym
- MIAKTR
- Status last verified
- Mar 2022
- First submitted
- 25 Jun 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Self-Management in Adult Kidney Transplant Recipients Versus Routine Care
- ClinicalTrials.gov ID
- NCT04956406
- Acronym / sponsor ID
- MIAKTR / 0000
- Conditions
- Motivational Interviewing, Adult, Kidney Transplantation, Self-Management, Treatment Adherence, Medication Adherence
- Keywords
- Motivational Interviewing, Recipient, Kidney Transplantation, Self-Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIAKTR | Experimental | Behavioral: Motivational Interviewing for Adult Kidney Transplant RecipientsMIAKTR is an acronym that defines Motivational Interviewing for Adult Kidney Transplant Recipients |
| Control Group | Active comparator | Other: Routine careroutine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Request to leave work
- Development of rejection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing for Adult Kidney Transplant RecipientsMotivational 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 | Behavioural | MIAKTR |
| Routine careThe control group will be provided with routine care( face-to-face care standard training) by the nurse educator at the transplant outpatient clinic. | Other | Control Group |
Primary outcome
Self-management scale
Time frame: Change from Baseline Self Management at 3 months
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.
VAS for medication adherence
Time frame: Change from Baseline VAS for Medication Adherence at 3 months
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
VAS for self care
Time frame: Change from Baseline VAS for self care at 3 months
The rating will be done as 0-100. 0: "I cannot provide my own care".100:"I am able to provide my own care".
2 secondary outcomes
Glomerular Filtration Rate (GFR)
Time frame: Change from Baseline GFR at 3 months
Serum Creatinine
Time frame: Change from Baseline Serum Creatinine at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing for Adult Kidney Transplant Recipients and Routine care in people with Motivational Interviewing and Adult, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Çiğdem Erdem, MSc (+905075011397, cgdmctn07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management scale (time frame: Change from Baseline Self Management at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.