Motivational InterviewingNCT06733662
The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients
A study testing Experimental: Education-based motivational interviewing Group in people with Motivational Interviewing and COPD, run by Kahramanmaraş İstiklal University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial will be conducted to evaluate the effect of education and motivational interviewing on treatment adherence and self-care power in COPD patients. Hypotheses of the Study; H1: Education and motivational interviewing in COPD patients increase treatment adherence in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motivational Interviewing, COPD
- What is being tested?
- Experimental: Education-based motivational interviewing Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 15 Feb 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
- Confirmed diagnosis of COPD for at least 6 months
- Admitted to the chest clinic
- No communication problems
- Patients who volunteered to participate in the study.
Who cannot join
- In the period of exacerbation
- Uncooperative due to dyspnea
- With a malignant disease
- Patients with a confirmed diagnosis of psychiatric illness
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
Kahramanmaraş Istiklal Universty
Kahramanmaraş
Yasemin SAZAK, 05414474944, yaseminsazak44@gmail.com
Meltem KALAYCI
About this study
Official title: The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients: A Randomized Controlled Trial
This randomized controlled trial will be conducted to evaluate the effect of education and motivational interviewing on treatment adherence and self-care power in COPD patients.
Hypotheses of the Study; H1: Education and motivational interviewing in COPD patients increase treatment adherence in patients.
H2: Education and motivational interviewing in COPD patients increase self-care power in patients.
There will be two groups in the study: control and intervention groups. Before the intervention, pre-test data will be collected in the control and intervention groups. After the intervention, post-test data will be collected in both groups in line with the data collection forms.
Read the detailed description
In line with the randomization list, patients will be assigned to the intervention and control groups in line with the inclusion criteria. Pre-test data will be collected face-to-face in the intervention group in accordance with the data collection forms. After collecting the pre-test data, the patient will be allowed to rest for about 10 minutes, and then COPD training will be given to the patient in a single session lasting about 45-50 minutes in line with the training booklet and by evaluating the pre-test data. The education booklet will be given to the patient. On the 3rd day, the first session of motivational interview will be held. On the 5th day and 7th day and 15th day, motivational interview sessions will continue with the patients. During the motivational interview, patients will be supported in line with the training booklet. On the 30th day, the patient will be interviewed face-to-face and post-test data will be collected.
Patients in the control group will be interviewed and no intervention will be made after the pre-tests are applied. Patients in the control group will continue their routine controls. In the final test (1st month), an appointment date will be set with the patient and the final test data will be collected face-to-face.
- Conditions
- Motivational Interviewing, COPD
- Being tested
- Experimental: Education-based motivational interviewing Group
- Keywords
- Self-care, Treatment adherence, Education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Education-based motivational interviewing GroupBehavioural
The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients
| Study group | Role | What they receive |
|---|---|---|
| Education-based motivational interviewing Group | Experimental | Patients in the intervention group will be given COPD education lasting approximately 45-50 minutes in a single session in line with the education booklet and by evaluating the pre-test data. On the 3rd day, the first session of motivational interview will be held. On the 5th day and 7th day and 15th day, motivational interview sessions will continue with the patients. Receives: Behavioral: Experimental: Education-based motivational interviewing Group |
| Control group | No intervention | There will be no intervention for individuals in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky 8-item Medication Adherence Scale
It is a scale that assesses self-reported medication use behaviors of the patient. It consists of eight questions. A validation study in Turkish was conducted by Oğuzülgen et al. in 2014. While the first seven questions are answered as "yes/no", the eighth question is answered on a five-point Likert scale as "never/rarely", "sometimes", "sometimes", "usually" and "always". Morisky 8-item medication adherence scale is calculated between 0-8 points.
Measured: 0 days
Morisky 8-item Medication Adherence Scale
It is a scale that assesses self-reported medication use behaviors of the patient. It consists of eight questions. A validation study in Turkish was conducted by Oğuzülgen et al. in 2014. While the first seven questions are answered as "yes/no", the eighth question is answered on a five-point Likert scale as "never/rarely", "sometimes", "sometimes", "usually" and "always". Morisky 8-item medication adherence scale is calculated between 0-8 points.
Measured: 30 days
Self-care Agency Scale
The scale was developed by Kearney and Fleischer and its validity and reliability study in Turkey was conducted by Nahcivan in 1993. In Nahcivan's study, the Cronbach's alpha coefficient of the scale was found to be 0.92. This scale, in which individuals self-assess their ability or power to perform self-care actions, consists of 35 items. The maximum score to be obtained from the scale is 140. As the score obtained from the scale increases, the self-care power of the patients also increases.
Measured: 0 days
Self-care Agency Scale
The scale was developed by Kearney and Fleischer and its validity and reliability study in Turkey was conducted by Nahcivan in 1993. In Nahcivan's study, the Cronbach's alpha coefficient of the scale was found to be 0.92. This scale, in which individuals self-assess their ability or power to perform self-care actions, consists of 35 items. The maximum score to be obtained from the scale is 140. As the score obtained from the scale increases, the self-care power of the patients also increases.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 Aug 2024
- Primary completion10 Jan 2025 (estimated)
- Study completion15 Feb 2025 (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.
- 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaraş İstiklal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sazak, Kahramanmaraş İstiklal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733662
- Sponsor's protocol ID
- IstiklalU-YSazak-003
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06733662
- Acronym / sponsor ID
- IstiklalU-YSazak-003
- Conditions
- Motivational Interviewing, COPD
- Keywords
- Self-care, Treatment adherence, Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kahramanmaraş İstiklal UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 13 Dec 2024 (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 will be conducted to evaluate the effect of education and motivational interviewing on treatment adherence and self-care power in COPD patients.
Hypotheses of the Study; H1: Education and motivational interviewing in COPD patients increase treatment adherence in patients.
H2: Education and motivational interviewing in COPD patients increase self-care power in patients.
There will be two groups in the study: control and intervention groups. Before the intervention, pre-test data will be collected in the control and intervention groups. After the intervention, post-test data will be collected in both groups in line with the data collection forms.
Detailed description
In line with the randomization list, patients will be assigned to the intervention and control groups in line with the inclusion criteria. Pre-test data will be collected face-to-face in the intervention group in accordance with the data collection forms. After collecting the pre-test data, the patient will be allowed to rest for about 10 minutes, and then COPD training will be given to the patient in a single session lasting about 45-50 minutes in line with the training booklet and by evaluating the pre-test data. The education booklet will be given to the patient. On the 3rd day, the first session of motivational interview will be held. On the 5th day and 7th day and 15th day, motivational interview sessions will continue with the patients. During the motivational interview, patients will be supported in line with the training booklet. On the 30th day, the patient will be interviewed face-to-face and post-test data will be collected.
Patients in the control group will be interviewed and no intervention will be made after the pre-tests are applied. Patients in the control group will continue their routine controls. In the final test (1st month), an appointment date will be set with the patient and the final test data will be collected face-to-face.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education-based motivational interviewing Group | Experimental | Behavioral: Experimental: Education-based motivational interviewing GroupPatients in the intervention group will be given COPD education lasting approximately 45-50 minutes in a single session in line with the education booklet and by evaluating the pre-test data. On the 3rd day, the first session of motivational interview will be held. On the 5th day and 7th day and 15th day, motivational interview sessions will continue with the patients. |
| Control group | No intervention | –There will be no intervention for individuals in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of COPD for at least 6 months
- Admitted to the chest clinic
- No communication problems
- Patients who volunteered to participate in the study.
Key exclusion criteria (4 listed)
- In the period of exacerbation
- Uncooperative due to dyspnea
- With a malignant disease
- Patients with a confirmed diagnosis of psychiatric illness
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 |
|---|---|---|
| Experimental: Education-based motivational interviewing GroupThe Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients | Behavioural | Education-based motivational interviewing Group |
Primary outcome
Morisky 8-item Medication Adherence Scale
Time frame: 0 days
It is a scale that assesses self-reported medication use behaviors of the patient. It consists of eight questions. A validation study in Turkish was conducted by Oğuzülgen et al. in 2014. While the first seven questions are answered as "yes/no", the eighth question is answered on a five-point Likert scale as "never/rarely", "sometimes", "sometimes", "usually" and "always". Morisky 8-item medication adherence scale is calculated between 0-8 points.
Morisky 8-item Medication Adherence Scale
Time frame: 30 days
It is a scale that assesses self-reported medication use behaviors of the patient. It consists of eight questions. A validation study in Turkish was conducted by Oğuzülgen et al. in 2014. While the first seven questions are answered as "yes/no", the eighth question is answered on a five-point Likert scale as "never/rarely", "sometimes", "sometimes", "usually" and "always". Morisky 8-item medication adherence scale is calculated between 0-8 points.
Self-care Agency Scale
Time frame: 0 days
The scale was developed by Kearney and Fleischer and its validity and reliability study in Turkey was conducted by Nahcivan in 1993. In Nahcivan's study, the Cronbach's alpha coefficient of the scale was found to be 0.92. This scale, in which individuals self-assess their ability or power to perform self-care actions, consists of 35 items. The maximum score to be obtained from the scale is 140. As the score obtained from the scale increases, the self-care power of the patients also increases.
Self-care Agency Scale
Time frame: 30 days
The scale was developed by Kearney and Fleischer and its validity and reliability study in Turkey was conducted by Nahcivan in 1993. In Nahcivan's study, the Cronbach's alpha coefficient of the scale was found to be 0.92. This scale, in which individuals self-assess their ability or power to perform self-care actions, consists of 35 items. The maximum score to be obtained from the scale is 140. As the score obtained from the scale increases, the self-care power of the patients also increases.
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 13 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Education-based motivational interviewing Group in people with Motivational Interviewing and COPD, run by Kahramanmaraş İstiklal 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 4 inclusion and 4 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 13 Dec 2024. 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 Yasemin SAZAK (541 447 49 44, yasemin.sazak@istiklal.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morisky 8-item Medication Adherence Scale (time frame: 0 days). The study lists 4 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 13 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.