Clinical trial NCT05008211: Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Noninvasive Ventilation
Keywords: Chronic Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease
Noninvasive Ventilation
hospital admission
respiratory insufficiency
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University Grants Committee, Hong Kong
name: Hospital Authority, Hong Kong
First posted: 2021-08-17
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Domiciliary NIV adherence
timeFrame: baseline
measure: Domiciliary NIV adherence
timeFrame: 3rd month
measure: Domiciliary NIV adherence
timeFrame: 6th month
measure: Domiciliary NIV adherence
timeFrame: 12th month
Secondary outcomes:
measure: Venous bicarbonate (HCO3-) level
timeFrame: baseline
measure: Venous bicarbonate (HCO3-) level
timeFrame: 3rd month
measure: Venous bicarbonate (HCO3-) level
timeFrame: 6th month
measure: Chinese Pittsburgh Sleep Quality Index (CPSQI)
timeFrame: baseline
measure: Chinese Pittsburgh Sleep Quality Index (CPSQI)
timeFrame: 3rd month
measure: Chinese Pittsburgh Sleep Quality Index (CPSQI)
timeFrame: 6th month
measure: Chinese Pittsburgh Sleep Quality Index (CPSQI)
timeFrame: 12th month
measure: Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
timeFrame: baseline
measure: Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
timeFrame: 3rd month
measure: Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
timeFrame: 6th month
measure: Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
timeFrame: 12th month
measure: Hospital admissions and survival rate
timeFrame: baseline
measure: Hospital admissions and survival rate
timeFrame: 12th month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine and Geriatrics, United Christian Hospital
Study officials:
affiliation: School of Nursing, LKS Faculty of Medicine, HKU
name: Doris SF Yu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: United Christian Hospital
name: Henry Poon, PhD
role: STUDY_CHAIR
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