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

November 25, 2025 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Medicine and Geriatrics, United Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Information-Motivation-Behavioral skills (IMB) model-based intervention
A six-week programme
Placebo Comparator: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
3rd month
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.
6th month
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.
12th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous bicarbonate (HCO3-) level
Time Frame: baseline
estimation for level of hypercapnia
baseline
Venous bicarbonate (HCO3-) level
Time Frame: 3rd month
estimation for level of hypercapnia
3rd month
Venous bicarbonate (HCO3-) level
Time Frame: 6th month
estimation for level of hypercapnia
6th month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time Frame: baseline
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.
baseline
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time Frame: 3rd month
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.
3rd month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time Frame: 6th month
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.
6th month
Chinese Pittsburgh Sleep Quality Index (CPSQI)
Time Frame: 12th month
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.
12th month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time Frame: baseline
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.
baseline
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time Frame: 3rd month
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.
3rd month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time Frame: 6th month
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.
6th month
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
Time Frame: 12th month
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.
12th month
Hospital admissions and survival rate
Time Frame: baseline
record the number of hospital admissions
baseline
Hospital admissions and survival rate
Time Frame: 12th month
record the number of hospital admissions
12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Hospital Authority, Hong Kong
University Grants Committee, Hong Kong

Investigators

  • Principal Investigator: Doris SF Yu, PhD, School of Nursing, LKS Faculty of Medicine, HKU
  • Study Chair: Henry Poon, PhD, United Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Actual)

October 16, 2024

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMB-NIV-CHRF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only study investigators and research assistants involved in the study will have access to the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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