Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients
NCT ID: NCT05008211
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
124 participants
INTERVENTIONAL
2021-09-16
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Management of Noninvasive Ventilation in Hypoxemic Patients
NCT03250416
Non-invasive Ventilation Versus Sham Ventilation in Chronic Obstructive Pulmonary Disease (COPD)
NCT00429156
A Study on the Assessment of Difficult Weaning in Patients With Acute Respiratory Failure Undergoing Mechanical Ventilation Based on Machine Learning EIT-pendelluft: A Multicenter Retrospective Study.
NCT06756204
Deventilation Dyspnea in COPD Patients Using NIV
NCT03503123
Clinical Assessment Method in Patients Using Non-invasive Ventilation
NCT04053777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Usual Care: There is a respiratory team of health care professionals responsible for patients requiring domiciliary non-invasive ventilation (NIV). The team is led by a Medical Consultant and with respiratory nurse(s) as team members who are responsible for assisting patients or their family to initiate domiciliary NIV and teaching the relevant technical skills. The nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems such as leakage and pressure sore in hospital before discharge. Commercial leaflet or booklet according to the choice of ventilator with information of the ventilator, interface, accessories and the ventilator company will be provided to the patient.
Intervention:
There will be a respiratory team, same as the usual care, responsible for patients requiring domiciliary NIV in the intervention group. The IMB model-based intervention of this study is a six-week program consisted of a one-hour face-to-face home visit in the first week, two 20-minute telephone follow-ups in the second and fourth weeks, and a half-hour face-to-face follow-up at hospital in the sixth week, and a telephone consultation hotline during office hours.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
There will be a respiratory team, same as the usual care, responsible for patients requiring domiciliary NIV in the intervention group.
The IMB model-based intervention of this study is a six-week program consisted of a one-hour face-to-face home visit in the first week, two 20-minute telephone follow-ups in the second and fourth weeks, and a half-hour face-to-face follow-up at hospital in the sixth week, and a telephone consultation hotline during office hours.
There are three major components including information, motivation and behavioral skill interventions as proposed by the IMB model and will be deliberately arranged in the different sessions.
Information-Motivation-Behavioral skills (IMB) model-based intervention
A six-week programme
Control - usual care
There is a respiratory team of health care professionals responsible for patients requiring domiciliary NIV. The team is led by a Medical Consultant and with respiratory nurse(s) as team members who are responsible for assisting patients or their family to initiate domiciliary NIV and teaching the relevant technical skills. The nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems such as leakage and pressure sore in hospital before discharge. Commercial leaflet or booklet according to the choice of ventilator with information of the ventilator, interface, accessories and the ventilator company will be provided to the patient.
Control - usual care
he nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Information-Motivation-Behavioral skills (IMB) model-based intervention
A six-week programme
Control - usual care
he nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (2) using domiciliary NIV for ≥ 4 weeks, and
* (3) non-adherer (i.e., used domiciliary NIV for \< 4 hours per night or \< 70% of days or with a mean daily use \< 5 hours per day in the last 2 weeks)
Exclusion Criteria
* (2) diseases limiting life expectancy to ≤ one year; or
* (3) active malignancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Grants Committee, Hong Kong
OTHER_GOV
Hospital Authority, Hong Kong
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Yu, Doris Sau Fung
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Doris SF Yu, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Nursing, LKS Faculty of Medicine, HKU
Henry Poon, PhD
Role: STUDY_CHAIR
United Christian Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Medicine and Geriatrics, United Christian Hospital
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Elliott MW, Mulvey DA, Moxham J, Green M, Branthwaite MA. Domiciliary nocturnal nasal intermittent positive pressure ventilation in COPD: mechanisms underlying changes in arterial blood gas tensions. Eur Respir J. 1991 Oct;4(9):1044-52.
Ambrosino N, Montagna T, Nava S, Negri A, Brega S, Fracchia C, Zocchi L, Rampulla C. Short term effect of intermittent negative pressure ventilation in COPD patients with respiratory failure. Eur Respir J. 1990 May;3(5):502-8.
Meecham Jones DJ, Paul EA, Jones PW, Wedzicha JA. Nasal pressure support ventilation plus oxygen compared with oxygen therapy alone in hypercapnic COPD. Am J Respir Crit Care Med. 1995 Aug;152(2):538-44. doi: 10.1164/ajrccm.152.2.7633704.
Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42.
Chu CM, Yu WC, Tam CM, Lam CW, Hui DS, Lai CK; Hong Kong Home Ventilation Registry; Hong Kong Thoracic Society. Home mechanical ventilation in Hong Kong. Eur Respir J. 2004 Jan;23(1):136-41. doi: 10.1183/09031936.03.00017803.
Simonds AK. Home Mechanical Ventilation: An Overview. Ann Am Thorac Soc. 2016 Nov;13(11):2035-2044. doi: 10.1513/AnnalsATS.201606-454FR.
Cheng SL, Chan VL, Chu CM. Compliance with home non-invasive ventilation. Respirology. 2012 May;17(4):735-6. doi: 10.1111/j.1440-1843.2012.02169.x.
Motor Neurone Disease: The Use of Non-Invasive Ventilation in the Management of Motor Neurone Disease [Internet]. London: National Institute for Health and Clinical Excellence (NICE); 2010 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK65383/
Simonds AK, Elliott MW. Outcome of domiciliary nasal intermittent positive pressure ventilation in restrictive and obstructive disorders. Thorax. 1995 Jun;50(6):604-9. doi: 10.1136/thx.50.6.604.
Leger P, Bedicam JM, Cornette A, Reybet-Degat O, Langevin B, Polu JM, Jeannin L, Robert D. Nasal intermittent positive pressure ventilation. Long-term follow-up in patients with severe chronic respiratory insufficiency. Chest. 1994 Jan;105(1):100-5. doi: 10.1378/chest.105.1.100.
Mehta S, Hill NS. Noninvasive ventilation. Am J Respir Crit Care Med. 2001 Feb;163(2):540-77. doi: 10.1164/ajrccm.163.2.9906116. No abstract available.
Shneerson JM, Simonds AK. Noninvasive ventilation for chest wall and neuromuscular disorders. Eur Respir J. 2002 Aug;20(2):480-7. doi: 10.1183/09031936.02.00404002.
Duiverman ML, Wempe JB, Bladder G, Vonk JM, Zijlstra JG, Kerstjens HA, Wijkstra PJ. Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial. Respir Res. 2011 Aug 23;12(1):112. doi: 10.1186/1465-9921-12-112.
Suraj KP, Jyothi E, Rakhi R. Role of Domiciliary Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease Patients Requiring Repeated Admissions with Acute Type II Respiratory Failure: A Prospective Cohort Study. Indian J Crit Care Med. 2018 Jun;22(6):397-401. doi: 10.4103/ijccm.IJCCM_61_18.
Blankenburg T, Benthin C, Pohl S, Bramer A, Kalbitz F, Lautenschlager C, Schutte W. Survival of Hypercapnic Patients with COPD and Obesity Hypoventilation Syndrome Treated with High Intensity Non Invasive Ventilation in the Daily Routine Care. Open Respir Med J. 2017 Jun 30;11:31-40. doi: 10.2174/1874306401711010031. eCollection 2017.
Duiverman ML, Windisch W, Storre JH, Wijkstra PJ. The role of NIV in chronic hypercapnic COPD following an acute exacerbation: the importance of patient selection? Ther Adv Respir Dis. 2016 Apr;10(2):149-57. doi: 10.1177/1753465815624645. Epub 2016 Jan 8.
Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.
Dreher M, Storre JH, Schmoor C, Windisch W. High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: a randomised crossover trial. Thorax. 2010 Apr;65(4):303-8. doi: 10.1136/thx.2009.124263.
McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.
Altintas N. Update: Non-Invasive Positive Pressure Ventilation in Chronic Respiratory Failure Due to COPD. COPD. 2016;13(1):110-21. doi: 10.3109/15412555.2015.1043520. Epub 2015 Sep 29.
Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451.
Struik FM, Lacasse Y, Goldstein RS, Kerstjens HA, Wijkstra PJ. Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. Respir Med. 2014 Feb;108(2):329-37. doi: 10.1016/j.rmed.2013.10.007. Epub 2013 Oct 14.
Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.
Dretzke J, Moore D, Dave C, Mukherjee R, Price MJ, Bayliss S, Wu X, Jordan RE, Turner AM. The effect of domiciliary noninvasive ventilation on clinical outcomes in stable and recently hospitalized patients with COPD: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2016 Sep 16;11:2269-2286. doi: 10.2147/COPD.S104238. eCollection 2016.
Farrero E, Prats E, Manresa F, Escarrabill J. Outcome of non-invasive domiciliary ventilation in elderly patients. Respir Med. 2007 Jun;101(6):1068-73. doi: 10.1016/j.rmed.2006.10.005. Epub 2006 Nov 28.
Callegari J, Magnet FS, Taubner S, Berger M, Schwarz SB, Windisch W, Storre JH. Interfaces and ventilator settings for long-term noninvasive ventilation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2017 Jun 28;12:1883-1889. doi: 10.2147/COPD.S132170. eCollection 2017.
Chang AY, Marsh S, Smith N, Neill A. Long-term community non-invasive ventilation. Intern Med J. 2010 Nov;40(11):764-71. doi: 10.1111/j.1445-5994.2010.02171.x.
Ulger AF, Poyraz B, Gulec Balbay E, Binay S. Our experience of 200 patients: usage and maintenance of long-term oxygen therapy and non-invasive ventilation devices at home. Int J Clin Exp Med. 2014 Jan 15;7(1):170-6. eCollection 2014.
Gale NK, Jawad M, Dave C, Turner AM. Adapting to domiciliary non-invasive ventilation in chronic obstructive pulmonary disease: a qualitative interview study. Palliat Med. 2015 Mar;29(3):268-77. doi: 10.1177/0269216314558327. Epub 2014 Dec 18.
Ennis J, Rohde K, Chaput JP, Buchholz A, Katz SL. Facilitators and Barriers to Noninvasive Ventilation Adherence in Youth with Nocturnal Hypoventilation Secondary to Obesity or Neuromuscular Disease. J Clin Sleep Med. 2015 Dec 15;11(12):1409-16. doi: 10.5664/jcsm.5276.
Mansell SK, Cutts S, Hackney I, Wood MJ, Hawksworth K, Creer DD, Kilbride C, Mandal S. Using domiciliary non-invasive ventilator data downloads to inform clinical decision-making to optimise ventilation delivery and patient compliance. BMJ Open Respir Res. 2018 Mar 3;5(1):e000238. doi: 10.1136/bmjresp-2017-000238. eCollection 2018.
Mayberry LS, Osborn CY. Empirical validation of the information-motivation-behavioral skills model of diabetes medication adherence: a framework for intervention. Diabetes Care. 2014;37(5):1246-53. doi: 10.2337/dc13-1828. Epub 2014 Mar 5.
Cooperman NA, Richter KP, Bernstein SL, Steinberg ML, Williams JM. Determining Smoking Cessation Related Information, Motivation, and Behavioral Skills among Opiate Dependent Smokers in Methadone Treatment. Subst Use Misuse. 2015 Apr;50(5):566-81. doi: 10.3109/10826084.2014.991405. Epub 2015 Jan 5.
Nelson LA, Wallston KA, Kripalani S, LeStourgeon LM, Williamson SE, Mayberry LS. Assessing barriers to diabetes medication adherence using the Information-Motivation-Behavioral skills model. Diabetes Res Clin Pract. 2018 Aug;142:374-384. doi: 10.1016/j.diabres.2018.05.046. Epub 2018 Jun 4.
Malatesha G, Singh NK, Bharija A, Rehani B, Goel A. Comparison of arterial and venous pH, bicarbonate, PCO2 and PO2 in initial emergency department assessment. Emerg Med J. 2007 Aug;24(8):569-71. doi: 10.1136/emj.2007.046979.
Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.
Ho RT, Fong TC. Factor structure of the Chinese version of the Pittsburgh sleep quality index in breast cancer patients. Sleep Med. 2014 May;15(5):565-9. doi: 10.1016/j.sleep.2013.10.019. Epub 2014 Feb 18.
Cheung LM, Wong WS. The effects of insomnia and internet addiction on depression in Hong Kong Chinese adolescents: an exploratory cross-sectional analysis. J Sleep Res. 2011 Jun;20(2):311-7. doi: 10.1111/j.1365-2869.2010.00883.x. Epub 2010 Aug 31.
Wong WS, Fielding R. Prevalence of insomnia among Chinese adults in Hong Kong: a population-based study. J Sleep Res. 2011 Mar;20(1 Pt 1):117-26. doi: 10.1111/j.1365-2869.2010.00822.x.
Chen R, Guan L, Wu W, Yang Z, Li X, Luo Q, Liang Z, Wang F, Guo B, Huo Y, Yang Y, Zhou L. The Chinese version of the Severe Respiratory Insufficiency questionnaire for patients with chronic hypercapnic chronic obstructive pulmonary disease receiving non-invasive positive pressure ventilation. BMJ Open. 2017 Aug 28;7(8):e017712. doi: 10.1136/bmjopen-2017-017712.
Yu DSF, Li PW, Lau JC, Cheung PSA, Ip M, Cheng SLL, Poon HCL, Iris Lee FK. Health Communication and Adherence to Noninvasive Ventilation in Chronic Hypercapnic Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451614. doi: 10.1001/jamanetworkopen.2024.51614.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Cheung PS, Chu CM. Non-invasive ventilation for COPD hospital and home use. The Hong Kong Medical Diary 2016; 21(9): 21-3.
Comer DM. An update on domiciliary non-invasive ventilation. J Pulm Respir Med 2014; 5: 234. doi:10.4172/2161-105x.1000234
Sabate E. Adherence to long-term therapies: Evidence for action. Geneva, Switzerland: World Health Organization, 2003.
Fisher WA, Fisher JD, Harman J. The Information-Motivation-Behavioral Skills Model: A general social psychological approach to understanding and promoting health behavior. In Suls, Wallston (Eds.), Social psychological foundations of health and illnes
Chang SJ, Choi S, Kim S, Song M. Intervention strategies based on Information-Motivation-Behavioral Skills Model for health behavior change: a systematic review. Asian Nurs Res 2014; 8: 172-81.
Kim YI, Park JS. Development and Evaluation of a Joint Health Self-management Program for the Elderly with Knee Osteoarthritis in Communities: Applying the IMB Model. J Korean Acad Community Health Nurs 2017; 28(1): 55-68.
To KW, Lee FKI. The effect of a theory-driven educational-intervention for improving adherence to inhalation therapy in patients with chronic obstructive pulmonary disease: A pilot study. Presented in Hong Kong College of Gerontology Nursing Scientifi
Matthews JNS. An introduction to randomized controlled clinical trials. London: Arnold, 2000.
Kee JL. Laboratory and diagnostic tests with nursing implications, 6th ed.. Upper Saddle River, New Jersey: Prentice Hall, 2002.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IMB-NIV-CHRF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.