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Chronic Obstructive Pulmonary Disease and Health Coaching

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Health coaching
Sponsored by
Harran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Health coaching, Social support, Symptom management

Eligibility Criteria

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

Inclusion Criteria: over 40 years old, diagnosed with COPD for at least 6 months, without stage III and IV heart failure, without any cancer diagnosis, no communication problems (such as those who do not have problems in expressing - themselves, no hearing problems), not diagnosed with cognitive and mental dysfunction (such as Alzheimer's, dementia, bipolar disorder, major depression) Patients who agree to participate in the study will be formed. Exclusion Criteria: with any cancer with stage IV heart failure patients requiring clinical follow-up due to acute COPD exacerbation

Sites / Locations

  • Osmaniye Korkut Ata UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health coaching group

Control group

Arm Description

The patients in the health coaching group will first be given data collection tools, and then the COPD patient information training created by the researcher will be given. For the first eight weeks after the training, face-to-face meetings will be held with patients once a week. Data collection tools will be applied to the patients again in the fourth week and 12 weeks after the interviews are over.

Data collection tools will be applied to the patients in the control group first, and then the COPD patient information training created by the researcher will be given. After the training, there will be no interviews with the patients, and data collection tools will be applied again in the 12th and 20th weeks.

Outcomes

Primary Outcome Measures

Social support
The social support levels perceived by the patients will be measured.The scale developed by Zimmet, Dahlem, Zimet, and Farley (1988) was adapted to Turkish by Eker et al. (2001) via its application to 50 psychiatry patients, 50 surgery patients and 50 normal individuals. The average participant age was 36. Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale with three sub-factors such as family, friends and significant other. Each sub-factor consists of four items. The scale is a 7-point Likert type including choices ranging from very strongly disagree (1) to very strongly agree (7). Higher scores obtained from the scale point to high levels of perceived social support.

Secondary Outcome Measures

symptom managament
Symptoms of Patients with COPD will be measured. The CAT was used to assess symptom burden in this study. The CAT, a patient-reported scale, evaluates the effect of COPD symptoms on an individual's health. The scale consists of eight items including cough, phlegm, chest tightness, breathlessness, activities, confidence, sleep and energy. Each item is rated on a six-point Likert scale ranging from 0 (no symptom) to 5 (very serious). The total score ranges from 0 to 40 points, with lower scores indicating better health status.

Full Information

First Posted
January 16, 2023
Last Updated
January 25, 2023
Sponsor
Harran University
Collaborators
Osmaniye Korkut Ata University
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1. Study Identification

Unique Protocol Identification Number
NCT05711654
Brief Title
Chronic Obstructive Pulmonary Disease and Health Coaching
Official Title
The Effect of Health Coaching on Perceived Social Support in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harran University
Collaborators
Osmaniye Korkut Ata University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to determine the effect of the health coaching approach applied to patients with Chronic Obstructive Pulmonary Disease on the perceived social support of the patients. Research Hypotheses: H0: Health coaching approach has no effect on perceived social support in patients with COPD. H1: Health coaching approach has an effect on perceived social support in patients with COPD.
Detailed Description
The current study is in the design of a single-blind randomized controlled trial. Patients were randomized into intervention group (n:34) and control group (n=34). Coaching interview will be held once a week for 6-8 weeks with the patients in the coaching group. Coaching sessions will be based on the social support the patient receives from family and friends. Both the coaching group and the control group will be given information about COPD. This information will be given face to face first. Later, the booklet of the training given will be delivered to the patients via message. The data was collected using the socio-demographic information form,COPD Assessment Test (CAT), and Multidimensional Scale of Perceived Social Support (MSPSS). Data Analysis will be done with SPSS package program

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Health coaching, Social support, Symptom management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Factorial Assignment
Masking
Participant
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health coaching group
Arm Type
Experimental
Arm Description
The patients in the health coaching group will first be given data collection tools, and then the COPD patient information training created by the researcher will be given. For the first eight weeks after the training, face-to-face meetings will be held with patients once a week. Data collection tools will be applied to the patients again in the fourth week and 12 weeks after the interviews are over.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Data collection tools will be applied to the patients in the control group first, and then the COPD patient information training created by the researcher will be given. After the training, there will be no interviews with the patients, and data collection tools will be applied again in the 12th and 20th weeks.
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
Coaching interview will be held with patients at regular intervals.
Primary Outcome Measure Information:
Title
Social support
Description
The social support levels perceived by the patients will be measured.The scale developed by Zimmet, Dahlem, Zimet, and Farley (1988) was adapted to Turkish by Eker et al. (2001) via its application to 50 psychiatry patients, 50 surgery patients and 50 normal individuals. The average participant age was 36. Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale with three sub-factors such as family, friends and significant other. Each sub-factor consists of four items. The scale is a 7-point Likert type including choices ranging from very strongly disagree (1) to very strongly agree (7). Higher scores obtained from the scale point to high levels of perceived social support.
Time Frame
A 6-8 week coaching interview will be held with each patient participating in the study. Each patient will be followed for a total of 20 weeks.
Secondary Outcome Measure Information:
Title
symptom managament
Description
Symptoms of Patients with COPD will be measured. The CAT was used to assess symptom burden in this study. The CAT, a patient-reported scale, evaluates the effect of COPD symptoms on an individual's health. The scale consists of eight items including cough, phlegm, chest tightness, breathlessness, activities, confidence, sleep and energy. Each item is rated on a six-point Likert scale ranging from 0 (no symptom) to 5 (very serious). The total score ranges from 0 to 40 points, with lower scores indicating better health status.
Time Frame
A 6-8 week coaching interview will be held with each patient participating in the study. Each patient will be followed for a total of 20 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 40 years old, diagnosed with COPD for at least 6 months, without stage III and IV heart failure, without any cancer diagnosis, no communication problems (such as those who do not have problems in expressing - themselves, no hearing problems), not diagnosed with cognitive and mental dysfunction (such as Alzheimer's, dementia, bipolar disorder, major depression) Patients who agree to participate in the study will be formed. Exclusion Criteria: with any cancer with stage IV heart failure patients requiring clinical follow-up due to acute COPD exacerbation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derya Tülüce, PhD
Phone
+905052933587
Email
drytlc87@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Derya Tülüce, PhD
Email
drytlc87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Tülüce, PhD
Organizational Affiliation
Osmaniye Korkut Ata University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osmaniye Korkut Ata University
City
Osmaniye
State/Province
Center
ZIP/Postal Code
80000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derya TULUCE, PhD, RN
Phone
+905052933587
Email
drytlc87@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Chronic Obstructive Pulmonary Disease and Health Coaching

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