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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05008211
Enrollment
124
Registered
2021-08-17
Start date
2021-09-16
Completion date
2025-06-30
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnic Respiratory Failure, Noninvasive Ventilation

Keywords

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

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.

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.

Interventions

OTHERInformation-Motivation-Behavioral skills (IMB) model-based intervention

A six-week programme

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

Sponsors

University Grants Committee, Hong Kong
CollaboratorOTHER_GOV
Hospital Authority, Hong Kong
CollaboratorOTHER_GOV
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Domiciliary NIV adherencebaselinethe 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.

Secondary

MeasureTime frameDescription
Venous bicarbonate (HCO3-) levelbaselineestimation for level of hypercapnia
Chinese Pittsburgh Sleep Quality Index (CPSQI)baseline19-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.
Chinese Severe Respiratory Insufficiency questionnaire (CSRI)baseline49 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.
Hospital admissions and survival ratebaselinerecord the number of hospital admissions

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026