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Nurse-led COPD Self-management Intervention

Primary Purpose

COPD, COPD Exacerbation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
patient education, training booklet, 3 months tele health
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD focused on measuring COPD, nursing, self-efficacy, self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denizli Public Hospitals Association, Buldan Chest Diseases Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

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

Control group received only general care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2020
Last Updated
January 30, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04459546
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
February 17, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, COPD Exacerbation
Keywords
COPD, nursing, self-efficacy, self-management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled pre-post test design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Study group intervention consists patient education, training booklet and 3 month follow-up.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group received only general care
Intervention Type
Behavioral
Intervention Name(s)
patient education, training booklet, 3 months tele health
Intervention Description
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 Outcome Measure Information:
Title
COPD Self-Efficacy Score
Description
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.
Time Frame
Change from baseline COPD self-efficacy score at 3 months
Title
COPD Assessment Test Score
Description
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.
Time Frame
Change from baseline COPD assessment test score at 3 months
Title
Anxiety Depression Score
Description
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.
Time Frame
Change from baseline anxiety depression test score at 3 months
Title
6-Minute Walk Test
Description
Each participant received a 6-minute walk test as recommended by the AmericanThoracic Society.
Time Frame
Change from baseline 6-minute walk distance at 3 months
Secondary Outcome Measure Information:
Title
Number of health care uses
Description
According to the patient's declaration, emergency room visit, chest diseases outpatient clinic and hospitalizations associated with respiration
Time Frame
Change in the number of initial health care use in the 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevin K Kurban, Prof. Dr.
Organizational Affiliation
Consultant, Responsible researcher
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Şenay Takmak, pHd
Organizational Affiliation
pHd student, Assistant researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denizli Public Hospitals Association, Buldan Chest Diseases Hospital
City
Denizli
ZIP/Postal Code
20000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be announced in a publication.
IPD Sharing Time Frame
Findings can be shared after the study has been published.
IPD Sharing 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.
IPD Sharing URL
http://acikerisim.pau.edu.tr/xmlui/handle/11499/28554
Citations:
PubMed Identifier
21251148
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.
Results Reference
background
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)
Results Reference
background
PubMed Identifier
25340578
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.
Results Reference
background
PubMed Identifier
20040088
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.
Results Reference
result

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Nurse-led COPD Self-management Intervention

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