Clinical trial NCT04459546: Nurse-led COPD Self-management Intervention
Official title: The Effect of Rational Drug Use and Symptom Control Training on Self-efficacy, Emotional Status and Clinical Parameters in COPD (Chronic Obstructive Pulmonary Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
COPD Exacerbation
Keywords: COPD
nursing
self-efficacy
self-management
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled pre-post test design
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The skills and the knowledge necessary in COPD management and interventions required to develop this skill have conceptualized as self-management. The complex structure of COPD self-management includes medication compliance, smoking cessation, maintaining and increasing exercise capacity, regulating nutrition, healthy lifestyle changes, vaccination and symptom management.

According to the GOLD (2017) report, copd self-management cannot be achieved only with didactic teaching. Skill acquisition, behavior change and motivational interventions should be applied with education. Among these interventions, action plans are among the tools frequently used in preventing tele-health COPD attacks. Action plans can be used effectively in COPD to prevent attacks, symptom management and reduce the risk of anxiety / depression. One objectives of self-management is to reduce use of health care. Symptom management; It has been stated that it is effective in reducing hospitalization and days of hospitalization especially in patients with COPD diseases.

In studies involving self-management in COPD, self-management interventions increase health-related quality of life, control symptom, reduce the risk of anxiety / depression, increase self-efficacy, reduce respiratory hospital stays, reduce severity and duration of attacks, and reduce mortality at low impact. It is stated that the interventions made in the GOLD (2017) report provide improvements for health-related quality of life and patient outcomes. Because of self-management is a multi-component concept, variety in type of intervention and follow-up make it difficult to reach generalizable evidence.

Although many health professionals work with patients with COPD, self-management interventions are known to be carried out mostly by nurses or by multidisciplinary groups involving nurses.

This study is an example of applicable self-management intervention in terms of disease information and general management, rational drug use, symptom control training and evaluation with medium-term monitoring. It can contribute to literature in terms of determining the effect of nurse-managed self-management intervention.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: COPD Self-Efficacy Score
timeFrame: Change from baseline COPD self-efficacy score at 3 months
measure: COPD Assessment Test Score
timeFrame: Change from baseline COPD assessment test score at 3 months
measure: Anxiety Depression Score
timeFrame: Change from baseline anxiety depression test score at 3 months
measure: 6-Minute Walk Test
timeFrame: Change from baseline 6-minute walk distance at 3 months
Secondary outcomes:
measure: Number of health care uses
timeFrame: Change in the number of initial health care use in the 3rd month
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Denizli Public Hospitals Association, Buldan Chest Diseases Hospital
Study officials:
affiliation: Consultant, Responsible researcher
name: Nevin K Kurban, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: pHd student, Assistant researcher
name: Şenay Takmak, pHd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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)
citation: 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.
citation: 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.