- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06733662
The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yasemin SAZAK
- Phone Number: 541 447 49 44
- Email: yasemin.sazak@istiklal.edu.tr
Study Locations
-
-
-
Kahramanmaraş, Turkey
- Recruiting
- Kahramanmaraş Istiklal Universty
-
Sub-Investigator:
- Meltem KALAYCI
-
Sub-Investigator:
- Nermin OLGUN
-
Contact:
- Yasemin SAZAK
- Phone Number: 05414474944
- Email: yaseminsazak44@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- In the period of exacerbation
- Uncooperative due to dyspnea
- With a malignant disease
- Patients with a confirmed diagnosis of psychiatric illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
There will be no intervention for individuals in this group.
|
|
|
Experimental: Education-based motivational interviewing Group
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.
|
The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0 days
|
|
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.
|
30 days
|
|
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.
|
0 days
|
|
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.
|
30 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IstiklalU-YSazak-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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