Hypercapnic Respiratory Failure Clinical Trial
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.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | October 15, 2024 |
Est. primary completion date | August 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Medicine and Geriatrics, United Christian Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Hospital Authority, Hong Kong, University Grants Committee, Hong Kong |
Hong Kong,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Venous bicarbonate (HCO3-) level | estimation for level of hypercapnia | baseline | |
Secondary | Venous bicarbonate (HCO3-) level | estimation for level of hypercapnia | 3rd month | |
Secondary | Venous bicarbonate (HCO3-) level | estimation for level of hypercapnia | 6th month | |
Secondary | 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. | baseline | |
Secondary | 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. | 3rd month | |
Secondary | 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. | 6th month | |
Secondary | 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. | 12th month | |
Secondary | 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. | baseline | |
Secondary | 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. | 3rd month | |
Secondary | 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. | 6th month | |
Secondary | 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. | 12th month | |
Secondary | Hospital admissions and survival rate | record the number of hospital admissions | baseline | |
Secondary | Hospital admissions and survival rate | record the number of hospital admissions | 12th month |
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