Chronic Obstructive Pulmonary DiseaseNCT05711654
Chronic Obstructive Pulmonary Disease and Health Coaching
A study testing Health coaching in people with Chronic Obstructive Pulmonary Disease, run by Harran University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- with any cancer
- with stage IV heart failure
- patients requiring clinical follow-up due to acute COPD exacerbation
Trial locations and contacts
1 site in 1 country.
Derya Tülüce, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Osmaniye Korkut Ata University
Osmaniye, Center, 80000
Derya TULUCE, PhD, RN, +905052933587, drytlc87@gmail.com
About this study
Official title: The Effect of Health Coaching on Perceived Social Support in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
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.
Read the 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Health coaching
- Keywords
- Chronic Obstructive Pulmonary Disease, Health coaching, Social support, Symptom management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
Coaching interview will be held with patients at regular intervals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Dec 2022
- Primary completion31 May 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Collaborators
- Osmaniye Korkut Ata University
- Responsible party
- Principal investigator, Derya TÜLÜCE, Harran University
- Investigators
- Derya Tülüce, PhD, Principal investigator, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711654
- Sponsor's protocol ID
- Osmaniye Korkut Ata University
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Coaching on Perceived Social Support in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05711654
- Acronym / sponsor ID
- Osmaniye Korkut Ata University
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Health coaching, Social support, Symptom management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Collaborators
- Osmaniye Korkut Ata University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Factorial Assignment
| Arm | Type | Receives |
|---|---|---|
| Health coaching group | Experimental | Behavioral: Health coachingThe 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. |
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (3 listed)
- with any cancer
- with stage IV heart failure
- patients requiring clinical follow-up due to acute COPD exacerbation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health coachingCoaching interview will be held with patients at regular intervals. | Behavioural | Health coaching group |
Primary outcome
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.
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.
1 secondary outcome
symptom managament
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya Tülüce, PhD contact
Derya Tülüce, PhD principal investigator
Osmaniye Korkut Ata University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coaching in people with Chronic Obstructive Pulmonary Disease, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derya Tülüce, PhD (+905052933587, drytlc87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.