Hypercapnic Respiratory FailureNCT05008211

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

A study testing Information-Motivation-Behavioral skills (IMB) model-based intervention in people with Hypercapnic Respiratory Failure and Noninvasive Ventilation, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypercapnic Respiratory Failure, Noninvasive Ventilation
What is being tested?: Information-Motivation-Behavioral skills (IMB) model-based intervention
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 1 siteHong Kong
Study dates: 16 Sep 2021to 30 Jun 2025
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Department of Medicine and Geriatrics, United Christian Hospital
Hong Kong

Other trials in Hong Kong

About this study

Official title: Effectiveness of an Information-Motivation-Behavioral Skills Model-based Intervention on Adherence to Domiciliary Non-invasive Ventilation of Patients With Chronic Hypercapnic Respiratory Failure: A Randomized Controlled Study

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.

Read the detailed description

The study design is a multi-center, 2-arm single-blind randomized controlled trial. The intervention group will receive an Information-Motivation-Behavioral (IMB) model-based intervention while the control group will receive the usual care.

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: Hypercapnic Respiratory Failure, Noninvasive Ventilation
Being tested: Information-Motivation-Behavioral skills (IMB) model-based intervention, Control - usual care
Keywords: Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Noninvasive Ventilation, hospital admission, respiratory insufficiency
Medical subject headings: Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Information-Motivation-Behavioral skills (IMB) model-based interventionOther
A six-week programme
Control - usual careOther
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

Study groups in NCT05008211
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Control - usual care

What is being measured

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

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12th month

Secondary outcomes (13)

Venous bicarbonate (HCO3-) level
estimation for level of hypercapnia
Measured: baseline
Venous bicarbonate (HCO3-) level
estimation for level of hypercapnia
Measured: 3rd month
Venous bicarbonate (HCO3-) level
estimation for level of hypercapnia
Measured: 6th month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
Measured: baseline
Chinese Pittsburgh Sleep Quality Index (CPSQI)
19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
Measured: 3rd month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
Measured: 6th month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
Measured: 12th month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
Measured: baseline
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
Measured: 3rd month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
Measured: 6th month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
Measured: 12th month
Hospital admissions and survival rate
record the number of hospital admissions
Measured: baseline
Hospital admissions and survival rate
record the number of hospital admissions
Measured: 12th month

Timeline

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

16 Sep 202130 Jun 2025

First posted17 Aug 2021
Study start16 Sep 2021
Primary completion16 Oct 2024
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (41)Papers the sponsor has linked to this study.
Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05008211
Sponsor's protocol ID: IMB-NIV-CHRF
Status last verified: Nov 2025
First submitted: 9 Aug 2021
Last updated: 28 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Only study investigators and research assistants involved in the study will have access to the data.

Publications

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.
PubMed 8143712
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.
PubMed 14738245
Simonds AK. Home Mechanical Ventilation: An Overview. Ann Am Thorac Soc. 2016 Nov;13(11):2035-2044. doi: 10.1513/AnnalsATS.201606-454FR.
PubMed 27560387
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.
PubMed 22420583
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/
PubMed 22171400
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.
PubMed 7638799
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.
PubMed 8275718
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.
PubMed 11179136
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.
PubMed 12212984
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.
PubMed 7633704
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.
PubMed 1756837
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.
PubMed 2376246
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.
PubMed 21861914
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.
PubMed 29962738
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.
PubMed 28839495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Role of HFNC During FOB in Patients With Respiratory Failure
Respiratory Failure, Respiratory Failure With Hypercapnia
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
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All Hypercapnic Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of an Information-Motivation-Behavioral Skills Model-based Intervention on Adherence to Domiciliary Non-invasive Ventilation of Patients With Chronic Hypercapnic Respiratory Failure: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT05008211
Acronym / sponsor ID: IMB-NIV-CHRF
Conditions: Hypercapnic Respiratory Failure, Noninvasive Ventilation
Keywords: Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Noninvasive Ventilation, hospital admission, respiratory insufficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Collaborators: University Grants Committee, Hong Kong, Hospital Authority, Hong Kong
Study start: 16 Sep 2021 (actual)
Primary completion: 16 Oct 2024 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 17 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Intervention:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: Information-Motivation-Behavioral skills (IMB) model-based interventionThere 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.
Control - usual care	Placebo comparator	Other: Control - usual careThere 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

(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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Information-Motivation-Behavioral skills (IMB) model-based interventionA six-week programme	Other	Intervention
Control - usual carehe 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	Other	Control - usual care

Primary outcome

Domiciliary NIV adherence
Time frame: baseline
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.
Domiciliary NIV adherence
Time frame: 3rd month
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.
Domiciliary NIV adherence
Time frame: 6th month
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.
Domiciliary NIV adherence
Time frame: 12th month
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.

13 secondary outcomes

Venous bicarbonate (HCO3-) level
Time frame: baseline
Venous bicarbonate (HCO3-) level
Time frame: 3rd month
Venous bicarbonate (HCO3-) level
Time frame: 6th month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time frame: baseline
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time frame: 3rd month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time frame: 6th month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time frame: 12th month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time frame: baseline
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time frame: 3rd month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time frame: 6th month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time frame: 12th month
Hospital admissions and survival rate
Time frame: baseline
Hospital admissions and survival rate
Time frame: 12th month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Results publication: PubMed 8143712Hormann 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.
Results publication: PubMed 14738245Chu 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.
Results publication: PubMed 27560387Simonds AK. Home Mechanical Ventilation: An Overview. Ann Am Thorac Soc. 2016 Nov;13(11):2035-2044. doi: 10.1513/AnnalsATS.201606-454FR.
Results publication: PubMed 22420583Cheng 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.
Results publication: PubMed 22171400Motor 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/
Results publication: PubMed 7638799Simonds 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.
Results publication: PubMed 8275718Leger 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.
Results publication: PubMed 11179136Mehta 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.
Results publication: PubMed 12212984Shneerson 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.
Results publication: PubMed 7633704Meecham 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.
Results publication: PubMed 1756837Elliott 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.
Results publication: PubMed 2376246Ambrosino 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.
Cheung PS, Chu CM. Non-invasive ventilation for COPD hospital and home use. The Hong Kong Medical Diary 2016; 21(9): 21-3.Link provided by the sponsor.
Comer DM. An update on domiciliary non-invasive ventilation. J Pulm Respir Med 2014; 5: 234. doi:10.4172/2161-105x.1000234Link provided by the sponsor.
Sabate E. Adherence to long-term therapies: Evidence for action. Geneva, Switzerland: World Health Organization, 2003.Link provided by the sponsor.
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 illnesLink provided by the sponsor.
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.Link provided by the sponsor.
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.Link provided by the sponsor.
Individual participant dataSharing planned: No. Only study investigators and research assistants involved in the study will have access to the data.

Related trials for Hypercapnic Respiratory Failure

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Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Doris SF Yu, PhD principal investigator

School of Nursing, LKS Faculty of Medicine, HKU

Henry Poon, PhD study chair

United Christian Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 28 Nov 2025. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?

Domiciliary NIV adherence (time frame: baseline). The study lists 4 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 NCT05008211, which also lists 41 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 28 Nov 2025.