NCT05054205

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

September 10, 2021

Last Update Submit

September 21, 2021

Conditions

Keywords

COPDMotivational interviewingSelf managementSelf-EfficacyPsychiatric nursing

Outcome Measures

Primary Outcomes (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.

    measuring self-efficacy levels at baseline

  • 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.

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

  • 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.

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

Secondary Outcomes (3)

  • Perception of dyspnea

    Measuring perception of dyspnea levels at baseline

  • Perception of dyspnea

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

  • Perception of dyspnea

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.The data were collected in three stages as pre-test, post-test and follow-up (after 30 day).

Behavioral: Motivational İnterviewing

Control group

NO INTERVENTION

Normal care was continued in the control group.

Interventions

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.

Also known as: Self- management training
Experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denizli Buldan Chest Diseases Hospital

Denizli, Buldan, 20400, Turkey (Türkiye)

Location

Related Publications (8)

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

  • 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).

    RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yeliz Karaçar, M.Sc.

    Denizli Buldan Chest Diseases Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 23, 2021

Study Start

March 2, 2018

Primary Completion

April 9, 2018

Study Completion

June 28, 2018

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations