NCT06733662

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 10, 2024

Last Update Submit

December 10, 2024

Conditions

Keywords

Self-careTreatment adherenceEducation

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    30 days

Study Arms (2)

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.

Behavioral: Experimental: Education-based motivational interviewing Group

Control group

NO INTERVENTION

There will be no intervention for individuals in this group.

Interventions

The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients

Education-based motivational interviewing Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • In the period of exacerbation
  • Uncooperative due to dyspnea
  • With a malignant disease
  • Patients with a confirmed diagnosis of psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Istiklal Universty

Kahramanmaraş, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 13, 2024

Study Start

August 15, 2024

Primary Completion

January 10, 2025

Study Completion

February 15, 2025

Last Updated

December 13, 2024

Record last verified: 2024-12

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