Medication AdherenceNCT06004102
Medication Adherence in Kidney Transplant
A study testing reminder text message in people with Medication Adherence, run by Akdeniz University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aims and Objective: The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients. Background: One of the most common problems encountered in transplant patients is incompatibility with immunosuppressive drugs, one of the most important reasons for graft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- reminder text message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 8 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Being a recipient of a kidney transplant for the first time
- Being a kidney transplant recipient at post-transplant month 6 with scheduled follow-up until month 9
- Ongoing immunosuppressive drug therapy
- Absence of any disability that hinders communication
- No diagnosis of psychological and mental problems
Show all 9Show fewer
- Being an active cell phone user
- Ability to read and write
- Voluntary participation in the research.
Who cannot join
- Hospitalization for any reason during the research period
- History of combined or dual organ transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Text Message Reminders on Immunosuppressive Medication Adherence Among Kidney Transplant Recipients: A Randomized Controlled Study
Aims and Objective: The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.
Background: One of the most common problems encountered in transplant patients is incompatibility with immunosuppressive drugs, one of the most important reasons for graft rejection.
Read more
Design: A randomized controlled trial was conducted from January to October 2021 and conducted in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines.
Methods: This randomized controlled trial included a total of 100 patients receiving a kidney transplant, 50 in the intervention group and 50 in the control group. Patients in the intervention group were sent text message reminders four times a day during the 6th to 9th months after transplantation. Control patients received no such intervention. Tacrolimus concentrations in the bloodstream were monitored for all participants through measurements taken at months 7,8, and 9. Data collection tools included Sociodemographic and Descriptive Characteristics Form and Immunosuppressive Medication Adherence Scale.
Research hypotheses H1- Sending text message reminders improves immunosuppressive medication adherence in kidney transplant recipients.
H2- Utilization of text messages as reminders has a significant influence on tacrolimus blood profiles in kidney transplant recipients.
H3- There is a correlation between the scores from the Immunosuppressive Medication Adherence Scale and mean tacrolimus plasma levels in kidney transplant recipients.
H4- There is a correlation between the sociodemographic and descriptive characteristics of kidney transplant recipients and their mean scores from the Immunosuppressive Medication Adherence Scale.
- Conditions
- Medication Adherence
- Being tested
- reminder text message
- Keywords
- kidney transplantation, reminder text messages, medication adherence, surgical nursing
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reminder text messageOther
The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.
| Study group | Role | What they receive |
|---|---|---|
| reminder text message | Experimental | At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the intervention groups as a pretest. Short text messages to remind the use of immunosuppressive medication and educational text messages were sent to patients in the intervention group four times a day, every day for three months. The intervention group also received educational text messages three days a week, in addition to such text message reminders.
The text message contents prepared for the intervention group were sent automatically to patients at specified times via the purchased program. At the end of the study, intervention groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest. Receives: Other: reminder text message |
| no intervention | No intervention | At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the control groups as a pretest. The control group did not receive any such intervention. At the end of the study, control groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of sending reminder text messages on immunosuppressive medication adherence
The IMAS is a validated an 11-item self-report questionnaire developed in 2015 to measure medication adherence in patients that have received solid organ transplants and are prescribed immunosuppressive drugs.
Measured: baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Jan 2021
- Primary completion1 Oct 2021
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Erdal, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004102
- Sponsor's protocol ID
- KAEK-315
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erdal K, Karazeybek E. Impact of text message reminders on immunosuppressive medication adherence among kidney transplant recipients: A randomized controlled study. J Eval Clin Pract. 2025 Feb;31(1):e14178. doi: 10.1111/jep.14178. Epub 2024 Oct 16.
PubMed 39415490
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Text Message Reminders on Immunosuppressive Medication Adherence Among Kidney Transplant Recipients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06004102
- Acronym / sponsor ID
- KAEK-315
- Conditions
- Medication Adherence
- Keywords
- kidney transplantation, reminder text messages, medication adherence, surgical nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 22 Aug 2023 (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.
Aims and Objective: The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.
Background: One of the most common problems encountered in transplant patients is incompatibility with immunosuppressive drugs, one of the most important reasons for graft rejection.
Design: A randomized controlled trial was conducted from January to October 2021 and conducted in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines.
Methods: This randomized controlled trial included a total of 100 patients receiving a kidney transplant, 50 in the intervention group and 50 in the control group. Patients in the intervention group were sent text message reminders four times a day during the 6th to 9th months after transplantation. Control patients received no such intervention. Tacrolimus concentrations in the bloodstream were monitored for all participants through measurements taken at months 7,8, and 9. Data collection tools included Sociodemographic and Descriptive Characteristics Form and Immunosuppressive Medication Adherence Scale.
Research hypotheses H1- Sending text message reminders improves immunosuppressive medication adherence in kidney transplant recipients.
H2- Utilization of text messages as reminders has a significant influence on tacrolimus blood profiles in kidney transplant recipients.
H3- There is a correlation between the scores from the Immunosuppressive Medication Adherence Scale and mean tacrolimus plasma levels in kidney transplant recipients.
H4- There is a correlation between the sociodemographic and descriptive characteristics of kidney transplant recipients and their mean scores from the Immunosuppressive Medication Adherence Scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reminder text message | Experimental | Other: reminder text messageAt the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the intervention groups as a pretest. Short text messages to remind the use of immunosuppressive medication and educational text messages were sent to patients in the intervention group four times a day, every day for three months. The intervention group also received educational text messages three days a week, in addition to such text message reminders. The text message contents prepared for the intervention group were sent automatically to patients at specified times via the purchased program. At the end of the study, intervention groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest. |
| no intervention | No intervention | –At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the control groups as a pretest. The control group did not receive any such intervention. At the end of the study, control groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Being a recipient of a kidney transplant for the first time
- Being a kidney transplant recipient at post-transplant month 6 with scheduled follow-up until month 9
- Ongoing immunosuppressive drug therapy
- Absence of any disability that hinders communication
Key exclusion criteria (2 listed)
- Hospitalization for any reason during the research period
- History of combined or dual organ transplantation.
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 |
|---|---|---|
| reminder text messageThe study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients. | Other | reminder text message |
Primary outcome
The effect of sending reminder text messages on immunosuppressive medication adherence
Time frame: baseline and 9 months
The IMAS is a validated an 11-item self-report questionnaire developed in 2015 to measure medication adherence in patients that have received solid organ transplants and are prescribed immunosuppressive drugs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 39415490Erdal K, Karazeybek E. Impact of text message reminders on immunosuppressive medication adherence among kidney transplant recipients: A randomized controlled study. J Eval Clin Pract. 2025 Feb;31(1):e14178. doi: 10.1111/jep.14178. Epub 2024 Oct 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reminder text message in people with Medication Adherence, run by Akdeniz University Hospital 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 29 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of sending reminder text messages on immunosuppressive medication adherence (time frame: baseline and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06004102, which also lists 1 linked publication.
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 29 Aug 2023.