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Completed

NCT Number: NCT04459546

Nurse-led COPD Self-management Intervention

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denizli Public Hospitals Association, Buldan Chest Diseases Hospital

Denizli, 20000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. COPD Self-Efficacy Score

    Time frame: Change from baseline COPD self-efficacy score at 3 months

    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.

  2. COPD Assessment Test Score

    Time frame: Change from baseline COPD assessment test score at 3 months

    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.

  3. Anxiety Depression Score

    Time frame: Change from baseline anxiety depression test score at 3 months

    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.

  4. 6-Minute Walk Test

    Time frame: Change from baseline 6-minute walk distance at 3 months

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

Secondary outcomes

  1. Number of health care uses

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

    According to the patient's declaration, emergency room visit, chest diseases outpatient clinic and hospitalizations associated with respiration

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2020
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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