Nurse-led COPD Self-management Intervention

NCT04459546 | Completed DMC

• 1 other identifier: 60116787-020/4317
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Chronic Obstructive Pulmonary Disease (COPD) disease highest mortality and morbidity of respiratory diseases that third cause of death in the world and Turkey. Purpose: Purpose of study improve self-efficacy, anxiety/depression, symptom control and exercise capacity, reduce use of health care of COPD patients. Method: The study was conducted with a randomized controlled design. This study were included 41 COPD patients (İntervention=20, Control=21). Data collection tools were patient description form, COPD Self-Efficacy Scale (CSES), COPD Assessment Test (CAT), Hospital Anxiety Depression Scale (HAD), 6-Minute Walk Test (MWT) and tele-health form. Intervention consists patient education, training booklet and 3 month follow-up. Control group patients received only general care. The final test was performed three months later.

Conditions

COPD; COPD Exacerbation

Keywords

COPD; nursing; self-efficacy; self-management

Outcome Measures

Primary Outcomes (4)

• COPD Self-Efficacy Score

  Scales were filled in by interviewing each participant.Scoring is done between 1-5 points. Increased score indicates an increase in self-efficacy in coping with respiratory distress.

  Change from baseline COPD self-efficacy score at 3 months

• COPD Assessment Test Score

  Scales were filled in by interviewing each participant.Scoring is done between 0-40 points. Increased points indicate that the severity of the disease decreases.

  Change from baseline COPD assessment test score at 3 months

• Anxiety Depression Score

  Scales were filled in by interviewing each participant. Turkey cut-off score of the scale used for anxiety, 10, were found to be 7 for depression. Participants who scored above these points were evaluated as risky.

  Change from baseline anxiety depression test score at 3 months

• 6-Minute Walk Test

  Each participant received a 6-minute walk test as recommended by the AmericanThoracic Society.

  Change from baseline 6-minute walk distance at 3 months

Secondary Outcomes (1)

• Number of health care uses

  Change in the number of initial health care use in the 3rd month

Study Arms (2)

Study group

EXPERIMENTAL

Study group intervention consists patient education, training booklet and 3 month follow-up.

Behavioral: patient education, training booklet, 3 months tele health

Control group

NO INTERVENTION

Control group received only general care

Interventions

patient education, training booklet, 3 months tele health BEHAVIORAL

Patient education includes general disease information, COPD self-management and symptom control. The education face-to-face and practical training was provided by the researcher. The training booklet was prepared by the researcher. The readability of the booklet was very easy and its comprehensibility was tested by pre-application. Tele monitoring was done by the researcher for support and motivation. The participants were called 4 times by phone.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis of COPD
• Being inpatient at chest diseases clinic
• Being literate
• Able to use a telephone
• No communication disabilities
• Being volunteers

You may not qualify if:

• Having mental illness
• Respiratory comorbidity (lung cancer, interstitial lung disease, pulmonary tuberculosis),
• Unable to attend the post-tests
• Not reachable by phone

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Denizli Public Hospitals Association, Buldan Chest Diseases Hospital

Denizli, 20000, Turkey (Türkiye)

Location

Related Publications (4)

• Kasikci MK. Using self-efficacy theory to educate a patient with chronic obstructive pulmonary disease: A case study of 1-year follow-up. Int J Nurs Pract. 2011 Feb;17(1):1-8. doi: 10.1111/j.1440-172X.2010.01898.x.

  PMID: 21251148 BACKGROUND

• Global Initiative for Chronic Obstructive Lung Disease, From the Global Strategy for the Diagnosis, Management and Prevention of COPD, GOLD 2017, p.139. https://goldcopd.org/wp-content/uploads/2017/02/wms-GOLD-2017-FINAL.pdf (access date: 10.08.2018)

  BACKGROUND

• Harrison SL, Janaudis-Ferreira T, Brooks D, Desveaux L, Goldstein RS. Self-management following an acute exacerbation of COPD: a systematic review. Chest. 2015 Mar;147(3):646-661. doi: 10.1378/chest.14-1658.

  PMID: 25340578 BACKGROUND

• Trappenburg JC, Koevoets L, de Weert-van Oene GH, Monninkhof EM, Bourbeau J, Troosters T, Verheij TJ, Lammers JW, Schrijvers AJ. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulm Med. 2009 Dec 29;9:52. doi: 10.1186/1471-2466-9-52.

  PMID: 20040088 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nevin K Kurban, Prof. Dr.

  Consultant, Responsible researcher

  STUDY DIRECTOR

• Şenay Takmak, pHd

  pHd student, Assistant researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Randomized controlled pre-post test design

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 7, 2020
• Study Start: August 28, 2018
• Primary Completion: February 17, 2019
• Study Completion: May 30, 2019
• Last Updated: February 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Findings can be shared after the study has been published.
• Access Criteria: The sociodemographic and disease-related characteristics of the participants, the pre-post-test findings including the answers to the research questions and statistical analyzes will be shared.

Locations

TU (1)