Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients

NCT05008211 | Completed

• 1 other identifier: IMB-NIV-CHRF
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Domiciliary non-invasive ventilation (NIV) is a standard care for improving survival rates of selected patients with chronic hypercapnic respiratory failure (CHRF) and to improve the patients' hypercapnia, sleep quality, health-related quality of life (QoL). Adherence is an important factor affecting clinical effectiveness of domiciliary NIV. Our previous study has noted the associations between poor domiciliary NIV adherence and increased number of clinical adverse events (p = 0.004) and increased hospitalization requiring acute NIV salvage (p = 0.042). However, there are very limited studies on adherence to domiciliary NIV in patients with CHRF. The only interventional study was a single-group pre-test post-test study and lack of a theoretical framework for guiding the intervention. This study is employing an Information-Motivation-Behavioral skills (IMB) model-based intervention to improve inhalation adherence in a group of chronic obstructive pulmonary disease (COPD) patients.

Conditions

Hypercapnic Respiratory Failure; Noninvasive Ventilation

Keywords

Chronic Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease; Noninvasive Ventilation; hospital admission; respiratory insufficiency

Outcome Measures

Primary Outcomes (4)

• Domiciliary NIV adherence

  the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.

  baseline

• Domiciliary NIV adherence

  the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.

  3rd month

• Domiciliary NIV adherence

  the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.

  6th month

• Domiciliary NIV adherence

  the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.

  12th month

Secondary Outcomes (13)

• Venous bicarbonate (HCO3-) level

  baseline

• Venous bicarbonate (HCO3-) level

  3rd month

• Venous bicarbonate (HCO3-) level

  6th month

• Chinese Pittsburgh Sleep Quality Index (CPSQI)

  baseline

• Chinese Pittsburgh Sleep Quality Index (CPSQI)

  3rd month

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Information-Motivation-Behavioral skills (IMB) model-based intervention

Control - usual care

PLACEBO COMPARATOR

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.

Other: Control - usual care

Interventions

Information-Motivation-Behavioral skills (IMB) model-based intervention OTHER

A six-week programme

Intervention

Control - usual care OTHER

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

Control - usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) CHRF (i.e., PaCO2 ≥ 7 kPa or 52.5 mmHg) for at least 4 weeks, and
• (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)

You may not qualify if:

• (1) known psychiatric disorders except anxiety and depression; or
• (2) diseases limiting life expectancy to ≤ one year; or
• (3) active malignancy

Sponsors & Collaborators

• The University of Hong Kong: lead
• University Grants Committee, Hong Kong: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

Department of Medicine and Geriatrics, United Christian Hospital

Hong Kong, Hong Kong

Location

Related Publications (41)

• 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.

  PMID: 8143712 RESULT

• 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.

  PMID: 14738245 RESULT

• Simonds AK. Home Mechanical Ventilation: An Overview. Ann Am Thorac Soc. 2016 Nov;13(11):2035-2044. doi: 10.1513/AnnalsATS.201606-454FR.

  PMID: 27560387 RESULT

• 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.

  PMID: 22420583 RESULT

• 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/

  PMID: 22171400 RESULT

• 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.

  PMID: 7638799 RESULT

• 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.

  PMID: 8275718 RESULT

• 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.

  PMID: 11179136 RESULT

• 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.

  PMID: 12212984 RESULT

• 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.

  PMID: 7633704 RESULT

• 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.

  PMID: 1756837 RESULT

• 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.

  PMID: 2376246 RESULT

• 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.

  PMID: 21861914 RESULT

• 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.

  PMID: 29962738 RESULT

• 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.

  PMID: 28839495 RESULT

• 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.

  PMID: 26746384 RESULT

• 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.

  PMID: 25066329 RESULT

• 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.

  PMID: 20388753 RESULT

• 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.

  PMID: 19213769 RESULT

• 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.

  PMID: 26418151 RESULT

• 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.

  PMID: 28528348 RESULT

• 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.

  PMID: 24157199 RESULT

• 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.

  PMID: 24912564 RESULT

• 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.

  PMID: 27698560 RESULT

• 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.

  PMID: 17126543 RESULT

• 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.

  PMID: 28721033 RESULT

• 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.

  PMID: 20059598 RESULT

• 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.

  PMID: 24482704 RESULT

• 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.

  PMID: 25524958 RESULT

• 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.

  PMID: 26235150 RESULT

• 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.

  PMID: 29531743 RESULT

• 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.

  PMID: 24598245 RESULT

• 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.

  PMID: 25559697 RESULT

• 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.

  PMID: 29879495 RESULT

• 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.

  PMID: 17652681 RESULT

• 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.

  PMID: 16155782 RESULT

• 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.

  PMID: 24759325 RESULT

• 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.

  PMID: 20819144 RESULT

• 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.

  PMID: 20408932 RESULT

• 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.

  PMID: 28851800 RESULT

• 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.

  PMID: 39724376 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Doris SF Yu, PhD

  School of Nursing, LKS Faculty of Medicine, HKU

  PRINCIPAL INVESTIGATOR

• Henry Poon, PhD

  United Christian Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 17, 2021
• Study Start: September 16, 2021
• Primary Completion: October 16, 2024
• Study Completion: June 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)