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Chronic Obstructive Pulmonary DiseaseNCT04256070

Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory Individuals With COPD

A study testing education and tele-consultation in people with Chronic Obstructive Pulmonary Disease and Self Efficacy, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the effect of education and tele-consultancy intervention based on Watson's Human Care Theory on self-efficacy and quality of life of individuals with COPD. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
education and tele-consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2020to 21 Jun 2022
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Who has been diagnosed with COPD for more than 6 months
  • No exacerbation for at least 4 weeks, stable period
  • Followed up at Akdeniz University Hospital Chest Diseases Polyclinic
  • Clear conscious (evaluated by Sandartize Mini-Mental Test higher than 23 points)
  • No verbal communication barriers
  • Individual phone owner
Show all 10Show fewer
  • No hearing or communication problems on the phone
  • 18 years and older
  • Literate
  • Agree to participate in the research

Who cannot join

  • Not getting enough points from the Standardized Mini-Mental Test
  • A diagnosis of malignancy (based on file information)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Akdeniz University

    Antalya, 07070

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory on Self-efficacy and Quality of Life Individuals With COPD

This study aims to investigate the effect of education and tele-consultancy intervention based on Watson's Human Care Theory on self-efficacy and quality of life of individuals with COPD.

Read the detailed description

: The research that a single-blinded randomized controlled trial, a total of 74 individuals, including 37 individual intervention and 37 individual control groups who applied to Akdeniz University Chest Diseases Polyclinic for consultation and follow-up, meeting the inclusion criteria, conducted between October 2020 - May 2022. In collecting data Information Form Based on Watson Human Care Theory, the Chronic Obstructive Pulmonary Disease Self-efficacy Scale, St. George Quality of Life Scale, and Pulmonary Function Test Form were used. Individuals in the intervention group were provided with training and consultancy based on Watson Human Care Theory, and an educational booklet prepared with current guides and expert opinions. Telephone counseling was provided in the 2nd, 4th, 6th, 8th, and 10th weeks after the first intervention in the intervention group. Routine follow-up of individuals in the control group was continued. The data of the scales in the intervention and control groups are collected in the 12th week. The individuals in the control group were given a training booklet at the end of the study. Statistical analysis of the data was done with SPSS 22.0 software package.

Being tested
education and tele-consultation
Keywords
chronic obstructive pulmonary disease, nursing, quality of life, self-efficacy, Watson's Human Care Theory
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.

  • education and tele-consultationBehavioural

    education and tele-consultation based on Watson's Human Care Theory

Study groups in NCT04256070
Study groupRoleWhat they receive
Education, tele-consultation and training bookletExperimental* Informed Consent Form will be taken in written from those who agree to participate in the research. * In the first intervention, Information Form Based on Watson's Human Care Theory, Chronic Obstructive Pulmonary Disease Self-efficacy Scale, St. George Quality of Life Scale, Respiratory Function Test Form data will be collected. Subsequently, education, counseling nursing care and education booklet based on Watson's Human Care Theory will be given. Teleconsultation based on Watson's Human Care Theory will be given during the intervention at weeks 2, 4, 6, 8 and 10. * 24-hour tele-consultancy will be given on subjects determined for the management of COPD in case of necessity at the request of the individual. * In the last intervention in the 12th week, face to face with the individual, Consultancy based on Watson Human Care Theory, Self-efficacy Scale, St. George Quality of Life Scale, Respiratory Function Test Form, Telephone Interview Evaluation Form will be applied.
Receives: Behavioral: education and tele-consultation
Standart care, no interventionNo intervention* Informed Consent Form will be taken in writing from those who agree to participate in the research. * At the first meeting, Information Form Based on Watson Human Care Theory, Self-efficacy Scale, St. George Quality of Life Scale, Respiratory Function Test Form data will be collected. Interventions will not be applied to individuals in this group and routine treatment and follow-up will continue. - COPD Self-efficacy Scale, face-to-face meeting at the end of the 12th week. George Quality of Life Scale, Respiratory Function Test Form will be repeated. A training booklet for COPD management will be provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic Obstructive Pulmonary Disease Self-Efficacy Scale

    To measure self-efficacy in Chronic Obstructive Pulmonary Disease (COPD), Wigal et al. (1991) developed The Chronic Obstructive Pulmonary Disease Self-Efficacy Scale. The total score is calculated by the score of each of the answers given. There are 34 items in the total of the subtitles, a minimum of 34 points and a maximum of 170 points. High scores indicate that the level of self-efficacy is high. To find the overall score of the subscales, the total score is divided by the number of items that make up the subscale. In comparison, if there is an increase in score in the posttest compared to the pretest, it is interpreted that the degree of confidence in managing breathing difficulties or avoiding increased. By translating the scale into Turkish, Kara and Mirici (2002) tested its validity and reliability. Cronbach's alpha value in the original version of the scale is 0.95; Cronbach's alpha value of the Turkish version was found to be 0.94.

    Measured: from baseline and at the end of the third months

Secondary outcomes (1)

  1. St. George's Respiratory Questionnaire

    St. George's Respiratory Questionnaire (SGRQ) is known to be associated with the most commonly used scales in respiratory diseases. SGRQ is a 50-item scale under three main titles developed in 2001: symptoms (8 items), activities (16 items), effects of the disease (26 items).

    It is a scale that investigates the relationship between dyspnea, sputum, cough, respiratory status, and daily activity, especially in individuals with COPD. Its highest score is 100 and it expresses the highest level of negative status. Cronbach's alpha value of SGRQ was calculated as 0.88 for the whole scale, and it was found in the validity analysis that it correlated significantly with similar scales (p <0.0001). The SGRQ scale was translated into Turkish by Polatlı et al. (2013) and its validity and reliability study was conducted. Correlation of Turkish version Cronbach's alpha value was found to be 0.90.

    Measured: from baseline and at the end of the third months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 Oct 2020
  3. Primary completion30 Apr 2022
  4. Study completion21 Jun 2022

Resources

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
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04256070
Sponsor's protocol ID
2012-KAEK-20, Karar no: 718
Status last verified
Jul 2022
First submitted
1 Feb 2020
Last updated
7 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.

    PubMed 35514131

  • Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

    PubMed 34495549

Questions about this trial

What is this clinical trial studying?

A study testing education and tele-consultation in people with Chronic Obstructive Pulmonary Disease and Self Efficacy, run by Akdeniz 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 10 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jul 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (time frame: from baseline and at the end of the third months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04256070, which also lists 2 linked publications.

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 7 Jul 2022.

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