Inflammatory Bowel Disease (IBD)NCT06971627
Telehealth Monitoring in Inflammatory Bowel Disease: Effects on Medication Compliance, Self-Efficacy, and Quality of Life
A study testing Nurse-led Telehealth Monitoring Program in people with Inflammatory Bowel Disease (IBD) and Medication Compliance, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of nurse-led telehealth monitoring on medication adherence, self-efficacy, and quality of life in individuals with inflammatory bowel disease (IBD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Medication Compliance, Quality of Life
- What is being tested?
- Nurse-led Telehealth Monitoring Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals aged 18 years or older
- Individuals aged 18 years or older
- Able to read and write in Turkish
- Diagnosed with inflammatory bowel disease (IBD) for at least 6 months
- In clinical remission (Harvey-Bradshaw Index score < 5 or Simple Clinical Colitis Activity Index score < 3)
- Able to use a smartphone
Show all 9Show fewer
- Have access to an online messaging application (e.g., WhatsApp) and a valid e-mail address
- Capable of downloading and using a mobile or computer-based video conferencing application (e.g., Zoom)
- Willing to participate in the study voluntarily
Who cannot join
- Diagnosed with any psychiatric or cognitive disorder
- Having any condition that impairs communication
- Pregnant women
- Patients receiving infusion-based treatment
- Having an advanced chronic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
Istanbul, 34098
Kimya Kılıçaslan, RN, PhD Candidate, +90 535 083 45 53, kimya.kilicaslan@iuc.edu.tr
About this study
Official title: The Effect of Telehealth Monitoring on Medication Compliance, Self-Efficacy and Quality of Life in Patients With İnflammatory Bowel Disease
This randomized controlled trial aims to evaluate the effect of nurse-led telehealth monitoring on medication adherence, self-efficacy, and quality of life in individuals with inflammatory bowel disease (IBD). The study will be conducted at the IBD Outpatient Clinic of Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty. Participants will be randomly assigned to either an intervention group receiving a 3-month structured telehealth program (including education, counseling, phone calls, and reminders) or a control group receiving only standard care and an educational booklet. Outcomes will be assessed at baseline and after 12 weeks.
Read the detailed description
This randomized controlled trial aims to assess the impact of a nurse-led telehealth monitoring program on medication adherence, self-efficacy, and quality of life in patients with inflammatory bowel disease (IBD). The study will be conducted at the IBD Outpatient Clinic, Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital.
Participants will be randomly assigned to either an intervention or control group. The intervention group will receive a 12-week structured telehealth program including an educational booklet, video content, a Zoom-based group session, biweekly phone calls, and reminder messages. The control group will receive only standard care and the educational booklet, with no additional intervention.
Assessments will be conducted at baseline (Week 0) and at the end of the intervention (Week 12) using validated tools: Harvey-Bradshaw Index (HBI), Simple Clinical Colitis Activity Index (SCCAI), Medication Adherence Report Scale (MARS), MedTake Test, IBD Self-Efficacy Scale, IBD Quality of Life Questionnaire, and IBD Distress Scale.
The effectiveness of the intervention will be determined by comparing pre- and post-intervention outcomes between the two groups.
- Conditions
- Inflammatory Bowel Disease (IBD), Medication Compliance, Quality of Life, Telehealth Monitoring
- Being tested
- Nurse-led Telehealth Monitoring Program, No intervention
- Keywords
- Inflammatory Bowel Disease, Medication Compliance, Self-Efficacy, Quality of Life, Telehealth Monitoring, Crohn&#39;s Disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Medication Adherence, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Telehealth Monitoring ProgramBehavioural
Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.
No interventionOther
Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks. Receives: Behavioral: Nurse-led Telehealth Monitoring Program |
| Control group | Other | Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medication Adherence Report Scale (MARS) scores
This scale assesses self-reported medication adherence behavior. The outcome will evaluate the change in MARS scores from baseline to week 12 to determine the impact of the telehealth intervention on adherence.
Measured: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Secondary outcomes (4)
Change in MedTake Test scores
The MedTake test evaluates patients' ability to understand and manage their oral medication regimen. This outcome will examine improvements in medication-taking skills from baseline to the end of the 12-week intervention.
Measured: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Change in Harvey-Bradshaw Index scores (for Crohn's Disease) and Change in Simple Clinical Colitis Activity Index scores (for Ulcerative Colitis)
These indices measure disease activity in Crohn's Disease and Ulcerative Colitis, respectively. The outcome will track changes in disease activity from baseline to week 12 following the telehealth monitoring.
Measured: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring
Change in Inflammatory Bowel Disease (IBD) Self-Efficacy Scale scores
This scale measures a patient's confidence in managing their IBD-related health challenges. The outcome will assess changes in self-efficacy levels between baseline and week 12.
Measured: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Change in Inflammatory Bowel Disease Questionnaire scores
This questionnaire evaluates the quality of life in patients with IBD. The outcome will assess the effect of the intervention on quality of life by comparing scores at baseline and after 12 weeks.
Measured: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start20 Apr 2024
- Primary completion20 Jul 2024
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- The study is designed as a randomized controlled trial with a pretest-posttest design, consisting of two groups: an intervention group and a control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Tülek, Istanbul University - Cerrahpasa
- Investigators
- Kimya Kılıçaslan, PhD Candidate, Principal investigator, Istanbul University - Cerrahpasa Institute of Graudate StudiesZeliha Tulek, PhD, Prof., Study director, Istanbul University - Cerrahpasa, Florence Nightingale Faculty of NursingAykut Ferhat Çelik, MD, Prof., Study chair, Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971627
- Sponsor's protocol ID
- Inflammatory Bowel Disease
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon M, Sinopoulou V, Lakunina S, Gjuladin-Hellon T, Bracewell K, Akobeng AK. Remote care through telehealth for people with inflammatory bowel disease. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014821. doi: 10.1002/14651858.CD014821.pub2.
PubMed 37140025Pang L, Liu H, Liu Z, Tan J, Zhou LY, Qiu Y, Lin X, He J, Li X, Lin S, Ghosh S, Mao R, Chen M. Role of Telemedicine in Inflammatory Bowel Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials. J Med Internet Res. 2022 Mar 24;24(3):e28978. doi: 10.2196/28978.
PubMed 35323120
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telehealth Monitoring on Medication Compliance, Self-Efficacy and Quality of Life in Patients With İnflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06971627
- Acronym / sponsor ID
- Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Disease (IBD), Medication Compliance, Quality of Life, Telehealth Monitoring
- Keywords
- Inflammatory Bowel Disease, Medication Compliance, Self-Efficacy, Quality of Life, Telehealth Monitoring, Crohn&#39;s Disease, Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 14 May 2025 (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.
This randomized controlled trial aims to evaluate the effect of nurse-led telehealth monitoring on medication adherence, self-efficacy, and quality of life in individuals with inflammatory bowel disease (IBD). The study will be conducted at the IBD Outpatient Clinic of Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty. Participants will be randomly assigned to either an intervention group receiving a 3-month structured telehealth program (including education, counseling, phone calls, and reminders) or a control group receiving only standard care and an educational booklet. Outcomes will be assessed at baseline and after 12 weeks.
Detailed description
This randomized controlled trial aims to assess the impact of a nurse-led telehealth monitoring program on medication adherence, self-efficacy, and quality of life in patients with inflammatory bowel disease (IBD). The study will be conducted at the IBD Outpatient Clinic, Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital.
Participants will be randomly assigned to either an intervention or control group. The intervention group will receive a 12-week structured telehealth program including an educational booklet, video content, a Zoom-based group session, biweekly phone calls, and reminder messages. The control group will receive only standard care and the educational booklet, with no additional intervention.
Assessments will be conducted at baseline (Week 0) and at the end of the intervention (Week 12) using validated tools: Harvey-Bradshaw Index (HBI), Simple Clinical Colitis Activity Index (SCCAI), Medication Adherence Report Scale (MARS), MedTake Test, IBD Self-Efficacy Scale, IBD Quality of Life Questionnaire, and IBD Distress Scale.
The effectiveness of the intervention will be determined by comparing pre- and post-intervention outcomes between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is designed as a randomized controlled trial with a pretest-posttest design, consisting of two groups: an intervention group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Nurse-led Telehealth Monitoring ProgramParticipants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks. |
| Control group | Other | Other: No interventionParticipants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals aged 18 years or older
- Individuals aged 18 years or older
- Able to read and write in Turkish
- Diagnosed with inflammatory bowel disease (IBD) for at least 6 months
- In clinical remission (Harvey-Bradshaw Index score < 5 or Simple Clinical Colitis Activity Index score < 3)
Key exclusion criteria (5 listed)
- Diagnosed with any psychiatric or cognitive disorder
- Having any condition that impairs communication
- Pregnant women
- Patients receiving infusion-based treatment
- Having an advanced chronic disease
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 |
|---|---|---|
| Nurse-led Telehealth Monitoring ProgramParticipants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks. | Behavioural | Intervention Group |
| No interventionParticipants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period. | Other | Control group |
Primary outcome
Change in Medication Adherence Report Scale (MARS) scores
Time frame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
This scale assesses self-reported medication adherence behavior. The outcome will evaluate the change in MARS scores from baseline to week 12 to determine the impact of the telehealth intervention on adherence.
4 secondary outcomes
Change in MedTake Test scores
Time frame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Change in Harvey-Bradshaw Index scores (for Crohn's Disease) and Change in Simple Clinical Colitis Activity Index scores (for Ulcerative Colitis)
Time frame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring
Change in Inflammatory Bowel Disease (IBD) Self-Efficacy Scale scores
Time frame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Change in Inflammatory Bowel Disease Questionnaire scores
Time frame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Results publication: PubMed 37140025Gordon M, Sinopoulou V, Lakunina S, Gjuladin-Hellon T, Bracewell K, Akobeng AK. Remote care through telehealth for people with inflammatory bowel disease. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014821. doi: 10.1002/14651858.CD014821.pub2.
- Results publication: PubMed 35323120Pang L, Liu H, Liu Z, Tan J, Zhou LY, Qiu Y, Lin X, He J, Li X, Lin S, Ghosh S, Mao R, Chen M. Role of Telemedicine in Inflammatory Bowel Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials. J Med Internet Res. 2022 Mar 24;24(3):e28978. doi: 10.2196/28978.
- 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.
Kimya Kılıçaslan, PhD Candidate principal investigator
Istanbul University - Cerrahpasa Institute of Graudate Studies
Zeliha Tulek, PhD, Prof. study director
Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing
Aykut Ferhat Çelik, MD, Prof. study chair
Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Telehealth Monitoring Program in people with Inflammatory Bowel Disease (IBD) and Medication Compliance, run by Istanbul University - Cerrahpasa 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 5 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimya Kılıçaslan, PhD Candidate (+90 535 083 45 53, kimya.kilicaslan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence Report Scale (MARS) scores (time frame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.). 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 NCT06971627, which also lists 2 linked publications.
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 14 May 2025.