NCT05711654

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 16, 2023

Last Update Submit

January 25, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseHealth coachingSocial supportSymptom management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • symptom managament

    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.

Study Arms (2)

Health coaching group

EXPERIMENTAL

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.

Behavioral: Health coaching

Control group

NO INTERVENTION

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.

Interventions

Health coachingBEHAVIORAL

Coaching interview will be held with patients at regular intervals.

Health coaching group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • with any cancer
  • with stage IV heart failure
  • patients requiring clinical follow-up due to acute COPD exacerbation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye Korkut Ata University

Osmaniye, Center, 80000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Derya Tülüce, PhD

    Osmaniye Korkut Ata University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derya Tülüce, PhD

CONTACT

+905052933587drytlc87@gmail.com

Derya Tülüce, PhD

CONTACT

drytlc87@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
None (Open Label)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Factorial Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Health Sciences

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 3, 2023

Study Start

December 1, 2022

Primary Completion

May 31, 2023

Study Completion

September 30, 2023

Last Updated

February 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)