Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial

Authors: Eleonora Volpato, Paolo Banfi, Francesco Pagnini

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

People with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits. Rather than being merely a consequence of symptom-related physical impairments these additional problems may be part of the clinical course of the condition. The relationship between the physical and psychological aspects of the condition is illustrated by the patterns of use of non-invasive ventilation (NIV); NIV is often rejected or used inappropriately, resulting in clinical deterioration and an increase in health care costs.
The study aims to analyse the effects of psychological support on the acceptance of, and adherence to, NIV. The primary outcome will be a latent variable related to indices of use of NIV equipment and adherence to treatment regime; while survival rates and psychological variables will constitute the secondary outcomes.

Methods

A two-arm randomised controlled trial will be conducted. We aim to recruit 150 COPD patients for whom NIV is indicated. The experimental group will receive a brief course of psychological support that will include counselling, relaxation and mindfulness-based exercises. In some cases, it will also include neuropsychological rehabilitation exercises. Support will be delivered via four to eight meetings at the HD Respiratory Rehabilitation Unit, at home or via telemedicine. Controls will receive standard care and watch educational videos related to the management of their disease.

Discussion

This investigation will gain insight about the role of a psychological intervention as part of a treatment plan during the process of adaptation to NIV in COPD patients.

Trial registration

ClinicalTrials.gov, ID: NCT02499653. Registered on 14 July 2015.
Appendix
Available only for authorised users
Literature
1.
World Health Organization. The world health report 2000: health systems: improving performance. World Health Organization. 2000.
2.
Institute for Health Metrics and Evaluation. The global burden of disease: generating evidence, guiding policy. 2013.
3.
Fabbri LM, Hurd SS. Global strategy for the diagnosis, management and prevention of COPD: 2003 update. Eur Respir J. 2003;22:1.CrossRefPubMed
4.
Wells KB. Detection of depressive disorder for patients receiving prepaid or fee-for-service care. Results from the Medical Outcomes Study. JAMA. 1989;262:3298–302.CrossRefPubMed
5.
Williams JW, Mulrow CD, Kroenke K, Dhanda R, Badgett RG, Omori D, Lee S. Case-finding for depression in primary care: a randomized trial. Am J Med. 1999;106(1):36–43.
6.
Doyle T, Palmer S, Johnson J, Babyak MA, Smith P, Mabe S, et al. Association of anxiety and depression with pulmonary-specific symptoms in chronic obstructive pulmonary disease. Int J Psychiatry Med. 2013;45:189–202.CrossRefPubMedPubMedCentral
7.
Di Marco F, Verga M, Reggente M, Maria Casanova F, Santus P, Blasi F, et al. Anxiety and depression in COPD patients: the roles of gender and disease severity. Respir Med. 2006;100:1767–74.CrossRefPubMed
8.
Gift AG, Plaut SM, Jacox A. Psychologic and physiologic factors related to dyspnea in subjects with chronic obstructive pulmonary disease. Heart Lung: J Crit Care. 1986;15(6):595–601.
9.
Gudmundsson G, Gislason T, Janson C, Lindberg E, Suppli Ulrik C, Brøndum E, et al. Depression, anxiety and health status after hospitalisation for COPD: a multicentre study in the Nordic countries. Respir Med. 2006;100:87–93.CrossRefPubMed
10.
van Ede L, Yzermans CJ, Brouwer HJ. Prevalence of depression in patients with chronic obstructive pulmonary disease: a systematic review. Thorax. 1999;54:688–92.CrossRefPubMedPubMedCentral
11.
Maurer J. Anxiety and depression in COPD: current understanding, unanswered questions, and research needs. Chest J. 2008;134:43S.CrossRef
12.
13.
Incalzi RA, Gemma A, Marra C, Muzzolon R, Capparella O, Carbonin P. Chronic obstructive pulmonary disease. an original model of cognitive decline. Am Rev Respir Dis. 1993;148:418–24.CrossRefPubMed
14.
Schou L, Østergaard B, Rasmussen LS, Rydahl-Hansen S, Phanareth K. Cognitive dysfunction in patients with chronic obstructive pulmonary disease—A systematic review. Respir Med. 2012;106:1071–81.CrossRefPubMed
15.
Antonelli-Incalzi R, Corsonello A, Trojano L, Pedone C, Acanfora D, Spada A, et al. Screening of cognitive impairment in chronic obstructive pulmonary disease. Dement Geriatr Cogn Disord. 2007;23:264–70.CrossRefPubMed
16.
Etnier JL, Berry M. Fluid intelligence in an older COPD sample after short- or long-term exercise. Med Sci Sports Exerc. 2001;33:1620–8.CrossRefPubMed
17.
Andreou G, Vlachos F, Makanikas K. Effects of chronic obstructive pulmonary disease and obstructive sleep apnea on cognitive functions: evidence for a common nature. Sleep Disord. 2014;2014:1–18.CrossRef
18.
Singh B, Mielke MM, Parsaik AK, Cha RH, Roberts RO, Scanlon PD, et al. A prospective study of chronic obstructive pulmonary disease and the risk for mild cognitive impairment. JAMA Neurol. 2014;71:581.CrossRefPubMedPubMedCentral
19.
Phillips D, Pagnini F. A mindful approach to chronic illness. In: In A. Le, C. T. Ngnoumen, E. Langer, editors. The Wiley Blackwell handbook of mindfulness. London: Wiley-Blackwell. 2014. p. 852–63.
20.
Lacasse Y, Goldstein R, Lasserson TJ, Martin S. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2006;4(4).
21.
Celli BR. Pulmonary rehabilitation in patients with COPD. Am J Respir Crit Care Med. 1995;152:861–4.CrossRefPubMed
22.
Pagnini F, Bosma CM, Phillips D, Langer E. Symptom changes in multiple sclerosis following psychological interventions: a systematic review. BMC Neurol. 2014;14(1):222.
23.
Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23:1296–310.CrossRefPubMed
24.
Restrepo RD, Alvarez MT, Wittnebel LD, Sorenson H, Wettstein R, Vines DL, et al. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis. 2008;3:371–84.CrossRefPubMedPubMedCentral
25.
Balkrishnan R, Christensen DB. Inhaled corticosteroid use and associated outcomes in elderly patients with moderate to severe chronic pulmonary disease. Clin Ther. 2000;22:452–69.CrossRefPubMed
26.
Chryssidis E, Frewin DB, Frith PA, Dawes ER. Compliance with aerosol therapy in COPD. N Z Med J. 1981;250:375–7.
27.
Dolce JJ, Crisp C, Manzella B, Richards JM, Hardin JM, Bailey WC. Medication adherence patterns in chronic obstructive pulmonary disease. Chest. 1991;99:837–41.CrossRefPubMed
28.
Antonelli Incalzi R, Marra C, Giordano A, Calcagni ML, Cappa A, Basso S, et al. Cognitive impairment in chronic obstructive pulmonary disease—a neuropsychological and SPECT study. J Neurol. 2003;250:325–32.CrossRefPubMed
29.
30.
Ko BS, Ahn S, Lim KS, Kim WY, Lee Y-S, Lee JH. Early failure of noninvasive ventilation in chronic obstructive pulmonary disease with acute hypercapnic respiratory failure. Intern Emerg Med. 2015;10:855–60.CrossRefPubMed
31.
32.
Hess DR. The growing role of noninvasive ventilation in patients requiring prolonged mechanical ventilation. Respir Care. 2012;57(6):900–20.
33.
Leiva-Fernández J, Leiva-Fernández F, García-Ruiz A, Prados-Torres D, Barnestein-Fonseca P. Efficacy of a multifactorial intervention on therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled trial. BMC Pulm Med. 2014;14(1):70.
34.
Borel J-C, Pepin J-L, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, et al. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirol Carlton Vic. 2014;19:857–65.CrossRef
35.
Adler D, Perrig S, Takahashi H, Espa F, Rodenstein D, Pépin JL, et al. Polysomnography in stable COPD under non-invasive ventilation to reduce patient-ventilator asynchrony and morning breathlessness. Sleep Breath Schlaf Atm. 2012;16:1081–90.CrossRef
36.
Decramer M, et al. Global Strategies for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: Global Initiative for Chronic Obstructive Lung Disease. 2015.
37.
GOLD. Global strategy for the diagnosis, management and prevention of COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2016. Available from: http://​www.​goldcopd.​org.
38.
Diagnostic APA. Statistical manual of mental disorders: DSM-5 (ed.). Washington, DC: American Psychiatric Association; 2013.
39.
Stein DJ, Phillips KA, Bolton D, Fulford KWM, Sadler JZ, Kendler KS. What is a mental/psychiatric disorder? From DSM-IV to DSM-V. Psychol Med. 2010;40(11):1759–65.
40.
41.
Volpato E, Banfi P, Rogers SM, Pagnini F. Relaxation techniques for people with chronic obstructive pulmonary disease: a systematic review and a meta-analysis. Evid-Based Complement Altern Med. 2015;2015:628365.CrossRef
42.
Schwartz JE, Jandorf L, Krupp LB. The measurement of fatigue: a new instrument. J Psychosom Res. 1993;37:753–62.CrossRefPubMed
43.
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRefPubMed
44.
Szende A, Oppe M, Devlin NJ, EuroQol Group. EQ-5D value sets: inventory, comparative review, and user guide. Dordrecht: Springer; 2007.CrossRef
45.
Balestroni G, Bertolotti G. EuroQol-5D (EQ-5D): an instrument for measuring quality of life. Monaldi Arch Chest Dis. 2012;78:155–9.PubMed
46.
Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006;60:631–7.CrossRefPubMed
47.
Pain D, Miglioretti M, Angelino E. Sviluppo della versione italiana del Brief-IPQ (Illness Perception Questionnaire, short version), strumento psicometrico per lo studio delle Rappresentazioni di Malattia. Psicol. Della Salute. 2006.
48.
Horne R, Weinman J. Patients’ beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999;47:555–67.CrossRefPubMed
49.
Gerbino G, Dimonte V, Albasi C, et al. Adesione alla terapia del paziente in emodialisi. G Ital Nefrol. 2011;28(4):416–24.PubMed
50.
Robins RW, Hendin HM, Trzesniewski KH. Measuring global self-esteem: Construct validation of a single-item measure and the Rosenberg Self-Esteem Scale. Personal Soc Psychol Bull. 2001;27(2):151–61.CrossRef
51.
Mioshi E, Dawson K, Mitchell J, Arnold R, Hodges JR. The Addenbrooke’s Cognitive Examination Revised (ACE-R): a brief cognitive test battery for dementia screening. Int J Geriatr Psychiatry. 2006;21:1078–85.CrossRefPubMed
52.
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990;113:941–8.CrossRefPubMed
53.
Murray CJL, Barber RM, Foreman KJ, Ozgoren AA, Abd-Allah F, Abera SF, et al. Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990–2013: quantifying the epidemiological transition. Lancet. 2015;386:2145–91.CrossRefPubMed
54.
Williams A, Evans R, Drummond M. Quality-adjusted life-years. Lancet. 1987;329:1372–3.CrossRef
55.
Murray CJ. Quantifying the burden of disease: the technical basis for disability-adjusted life years. Bull World Health Organ. 1994;72:429.PubMedPubMedCentral
56.
Ståhl E, Jansson SA, Jonsson AC, Svensson K, Lundbäck B, Andersson F. Health-related quality of life, utility, and productivity outcomes instruments: ease of completion by subjects with COPD. Health Qual Life Outcomes. 2003;1(1):18.
57.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4:353–65.CrossRefPubMed
58.
Groenwold RH, Donders ART, Roes KC. Dealing with missing outcome data in randomized trials and observational studies. Am J Epidemiol. 2012;175:210–7.CrossRefPubMed
59.
Groenwold RH, White IR, Donders ART. Missing covariate data in clinical research: when and when not to use the missing-indicator method for analysis. Can Med Assoc J. 2012;184:1265–9.CrossRef
Metadata
Title
A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial
Authors
Eleonora Volpato
Paolo Banfi
Francesco Pagnini
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1802-1

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial

Update

The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis

Study protocol

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

Letter

Short-term impact of celebrating the international clinical trial day: experience from Ethiopia

Study protocol

Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial

Study protocol

The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial