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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05711654
Other study ID # Osmaniye Korkut Ata University
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date September 30, 2023

Study information

Verified date January 2023
Source Harran University
Contact Derya Tülüce, PhD
Phone +905052933587
Email drytlc87@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date September 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health coaching
Coaching interview will be held with patients at regular intervals.

Locations

Country Name City State
Turkey Osmaniye Korkut Ata University Osmaniye Center

Sponsors (2)

Lead Sponsor Collaborator
Harran University Osmaniye Korkut Ata University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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. 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.
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