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COPDCOPDNCT05054205

Motivational Interview-based Self-management Training

A study testing Motivational İnterviewing in people with COPD and Motivational Interviewing, 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

Chronic Obstructive Pulmonary Disease (COPD) is an important chronic disease that causes increasing mortality and morbidity globally, as well as a social and economic burden. All symptoms (cough, sputum production, etc.), especially dyspnea in COPD, the chronicity of the disease and the need for long-term care limit… Read more about this study

Who is it for?
Any age
Conditions the study is for
COPD, Motivational Interviewing, Self Management
What is being tested?
Motivational İnterviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Mar 2018to 28 Jun 2018
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • To receive inpatient treatment with the diagnosis of COPD,
  • To be literate,
  • To have the cognitive and mental competence to answer questions,
  • Disease symptoms are at a level that does not prevent communication

Who cannot join

  • The patient is in an acute exacerbation period,
  • Having dyspnea at a level that prevents cooperation,
  • Presence of sensory loss related to vision, hearing and speech,
  • Presence of cognitive and mental impairment that prevents communication

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Denizli Buldan Chest Diseases Hospital

    Denizli, Buldan, 20400

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect on Self-effıcacy of Self-management Program Based on motıvatıonal ıntervıewing in Chronic Obstructive Pulmonary Disease (COPD) patıents: A Randomized Controlled Trial

Chronic Obstructive Pulmonary Disease (COPD) is an important chronic disease that causes increasing mortality and morbidity globally, as well as a social and economic burden. All symptoms (cough, sputum production, etc.), especially dyspnea in COPD, the chronicity of the disease and the need for long-term care limit the lives of the patients. Dyspnea occurring in COPD negatively affects the self-confidence of patients by restricting their activities of daily living, thus causing a decrease in their self-efficacy levels. Low self-efficacy levels cause patients to limit their activities more.

Nurses play an important role in ensuring the management of COPD, supporting patients to continue their activities of daily living, and increasing their self-efficacy levels. Nursing care that includes patient education and counseling is important in providing disease management and symptom control, and increasing the self-efficacy levels of patients. During self-management training, it is necessary to ensure that the patient is an active participant, to use a motivating communication style in the behavior change process and to encourage patients. In this process, it is stated that it is important to use motivational interview techniques in self-management training given by nurses.

Read the detailed description

This study was conducted to investigate the effect on self-efficacy of self-management education and motivational interview among COPD patients. This randomized controlled experimental study was conducted between March and May 2018 with 39 intervention and 39 control groups, a total of 78 patients in the Chest Diseases Clinic of Chest Diseases Hospital who were treated with COPD. In data collection; ''Patient Data Form'', ''Medical Research Council (MRC) Dyspnea Scale'', ''COPD Self Efficacy Scale (CSES)'' were used. To the experimental group; motivational interview based self-management education was given for 30-45 minutes with groups of 5-8 people, COPD education guide was given, questions were shared with the question-answer method and group interaction was provided. After the self-management education, 3 motivational interviews were conducted 3 days apart with 30-45 minutes. Normal care was continued in the control group. The data were collected in three stages as pre-test, post-test and follow-up. According to the research ethics, self-management education and COPD education guidelines were given to the control group and motivational interviews were conducted. In this study, written consent was obtained from the ethics committee, institutions and patients.

  • Self-efficacy levels and dyspnea perception levels of COPD patients are the dependent variables of the study.
  • Self-management training and motivational interviewing given to COPD patients are the independent variables of the research.
  • Control variables of the study; age, gender, marital status, education status, occupation, employment status, smoking status, duration of being a COPD patient, number of hospitalizations, drug use status, people living with at home, type of warming, participation in COPD education and Pulmonary Rehabilitation program.
  • H0: Self-management training and motivational interviewing given to COPD patients have no effect on self-efficacy and dyspnea perception.
  • H1: Self-management training and motivational interviewing given to COPD patients have an effect on self-efficacy and dyspnea perception.
  • All statistical analyzes were made SPSS 25 package program. The obtained data were analyzed by means of percentage distributions, mean, variance analysis in repeated measures, bonferroni analysis as a further analysis and t test in dependent groups.
Being tested
Motivational İnterviewing
Keywords
COPD, Motivational interviewing, Self management, Self-Efficacy, Psychiatric nursing
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.

  • Motivational İnterviewingBehavioural

    Also called Self- management training

    The most current version of Motivational İnterviewing (MI) is described in detail in Miller and Rollnick (2013) Motivational Interviewing: Helping people to change (3rd edition). Key qualities include:

    MI is a guiding style of communication, that sits between following (good listening) and directing (giving information and advice).

    MI is designed to empower people to change by drawing out their own meaning, importance and capacity for change.

    MI is based on a respectful and curious way of being with people that facilitates the natural process of change and honors client autonomy.

Study groups in NCT05054205
Study groupRoleWhat they receive
Experimental groupExperimentalTo the experimental group; motivational interview based self-management education was given for 30-45 minutes with groups of 5-8 people, COPD education guide was given, questions were shared with the question-answer method and group interaction was provided. After the self-management education, 3 motivational interviews were conducted 3 days apart with 30-45 minutes.The data were collected in three stages as pre-test, post-test and follow-up (after 30 day).
Receives: Behavioral: Motivational İnterviewing
Control groupNo interventionNormal care was continued in the control group.

What is being measured

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

  1. Self Efficacy

    COPD Self Efficacy Scale: The scale is composed of 34 items. It is a five-point Likert scale; one corresponds to 'I am not confident' (not efficacious), two 'I am a little confident' (efficacious), three 'I am confident to some extent' (efficacious), four 'I am quite confident' (efficacious) and 5 'I am very confident' (efficacious). The highest and lowest scores for the scale are 170 and 34, respectively. An increase in the self-efficacy scale mean score indicates that the patient's self-efficacy level has improved. Total or mean scores for the scale and its subscales are utilized for the evaluation of self-efficacy in patients with COPD.

    Measured: measuring self-efficacy levels at baseline

  2. Self Efficacy

    COPD Self Efficacy Scale: The scale is composed of 34 items. It is a five-point Likert scale; one corresponds to 'I am not confident' (not efficacious), two 'I am a little confident' (efficacious), three 'I am confident to some extent' (efficacious), four 'I am quite confident' (efficacious) and 5 'I am very confident' (efficacious). The highest and lowest scores for the scale are 170 and 34, respectively. An increase in the self-efficacy scale mean score indicates that the patient's self-efficacy level has improved. Total or mean scores for the scale and its subscales are utilized for the evaluation of self-efficacy in patients with COPD.

    Measured: Change in self-efficacy level immediately after completion of a two-week motivational interview-based self-management training

  3. Self Efficacy

    COPD Self Efficacy Scale: The scale is composed of 34 items. It is a five-point Likert scale; one corresponds to 'I am not confident' (not efficacious), two 'I am a little confident' (efficacious), three 'I am confident to some extent' (efficacious), four 'I am quite confident' (efficacious) and 5 'I am very confident' (efficacious). The highest and lowest scores for the scale are 170 and 34, respectively. An increase in the self-efficacy scale mean score indicates that the patient's self-efficacy level has improved. Total or mean scores for the scale and its subscales are utilized for the evaluation of self-efficacy in patients with COPD.

    Measured: Change in self-efficacy level one month after motivational interview-based self-management training

Secondary outcomes (3)
  1. Perception of dyspnea

    Medical Research Council Dyspnea Scale: The Medical Research Council Dyspnea Scale is a 0-4 point category scale in which one of five expressions related to the perception of dyspnea is selected to best describe the patient's dyspnea level. ''0 points'' no dyspnea ''4 points'' indicates very severe dyspnea.

    Measured: Measuring perception of dyspnea levels at baseline

  2. Perception of dyspnea

    Medical Research Council Dyspnea Scale: The Medical Research Council Dyspnea Scale is a 0-4 point category scale in which one of five expressions related to the perception of dyspnea is selected to best describe the patient's dyspnea level. ''0 points'' no dyspnea ''4 points'' indicates very severe dyspnea.

    Measured: Change in perception of dyspnea level immediately after completion of a two-week motivational interview-based self-management program

  3. Perception of dyspnea

    Medical Research Council Dyspnea Scale: The Medical Research Council Dyspnea Scale is a 0-4 point category scale in which one of five expressions related to the perception of dyspnea is selected to best describe the patient's dyspnea level. ''0 points'' no dyspnea ''4 points'' indicates very severe dyspnea.

    Measured: Change in perception of dyspnea level one month after motivational interview-based self-management training

Timeline

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

  1. First posted23 Sep 2021
  2. Study start2 Mar 2018
  3. Primary completion9 Apr 2018
  4. Study completion28 Jun 2018

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
Model description
This randomized controlled experimental study was conducted between March and May 2018 with 39 intervention and 39 control groups, a total of 78 patients in the Chest Diseases Clinic of Chest Diseases Hospital who were treated with COPD. In data collection; ''Patient Data Form'', ''Medical Research Council (MRC) Dyspnea Scale'', ''COPD Self Efficacy Scale (CSES)'' were used.To the experimental group; motivational interview based self-management education was given for 30-45 minutes with groups of 5-8 people, COPD education guide was given, questions were shared with the question-answer method and group interaction was provided. After the self-management education, 3 motivational interviews were conducted 3 days apart with 30-45 minutes. Normal care was continued in the control group. The data were collected in three stages as pre-test, post-test and follow-up.
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054205
Sponsor's protocol ID
53043469
Other IDs
HF-18005
Acronym
COPD
Status last verified
Sep 2021
First submitted
10 Sep 2021
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018. Available from: http://goldcopd.org.

  • Miller WR, Rollnick S. Motvational Interviewing. Motivasyonel Görüşme İnsanları Değişime Hazırlama. Karadağ F, Ögel K, Tezcan AE. (Ed), HYB Basım Yayın Matbaası, Ankara, 2009, 216-231.

  • Benzo R, Vickers K, Ernst D, Tucker S, McEvoy C, Lorig K. Development and feasibility of a self-management intervention for chronic obstructive pulmonary disease delivered with motivational interviewing strategies. J Cardiopulm Rehabil Prev. 2013 Mar-Apr;33(2):113-23. doi: 10.1097/HCR.0b013e318284ec67.

    PubMed 23434613
  • Abedi HA, Salimi S, Feizi A, et al. Assessment of relationship between self-efficacy and self-care in COPD Patients. Journal of Urmia Nursing and Midwifery Faculty, 2012, 10(1), 68-74.

  • Celli BR, Decramer M, Wedzicha JA, Wilson KC, Agusti A, Criner GJ, MacNee W, Make BJ, Rennard SI, Stockley RA, Vogelmeier C, Anzueto A, Au DH, Barnes PJ, Burgel PR, Calverley PM, Casanova C, Clini EM, Cooper CB, Coxson HO, Dusser DJ, Fabbri LM, Fahy B, Ferguson GT, Fisher A, Fletcher MJ, Hayot M, Hurst JR, Jones PW, Mahler DA, Maltais F, Mannino DM, Martinez FJ, Miravitlles M, Meek PM, Papi A, Rabe KF, Roche N, Sciurba FC, Sethi S, Siafakas N, Sin DD, Soriano JB, Stoller JK, Tashkin DP, Troosters T, Verleden GM, Verschakelen J, Vestbo J, Walsh JW, Washko GR, Wise RA, Wouters EF, ZuWallack RL; ATS/ERS Task Force for COPD Research. An Official American Thoracic Society/European Respiratory Society Statement: Research questions in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015 Apr 1;191(7):e4-e27. doi: 10.1164/rccm.201501-0044ST.

    PubMed 25830527
  • Chen SM, Creedy D, Lin HS, Wollin J. Effects of motivational interviewing intervention on self-management, psychological and glycemic outcomes in type 2 diabetes: a randomized controlled trial. Int J Nurs Stud. 2012 Jun;49(6):637-44. doi: 10.1016/j.ijnurstu.2011.11.011. Epub 2011 Dec 30.

    PubMed 22209215
  • Emme C, Mortensen EL, Rydahl-Hansen S, Ostergaard B, Phanareth K. Danish version of 'The COPD self-efficacy scale': translation and psychometric properties. Scand J Caring Sci. 2012 Sep;26(3):615-23. doi: 10.1111/j.1471-6712.2011.00963.x. Epub 2012 Jan 24.

    PubMed 22272564
  • World Health Organization. (2018). The top 10 causes of death. https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death (26 Mayıs 2018).

Questions about this trial

What is this clinical trial studying?

A study testing Motivational İnterviewing in people with COPD and Motivational Interviewing, 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 4 inclusion and 4 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 23 Sep 2021. 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?

Self Efficacy (time frame: measuring self-efficacy levels at baseline). The study lists 3 primary outcomes in all. 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 NCT05054205, which also lists 8 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 23 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.

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