HOTPAL-study

JRCT ID: jRCTs052230111

Registered date:10/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic respiratory failure (CRF)
• Date of first enrollment: 10/10/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Home oxygen therapy using cloud-based home healthcare system

Outcome(s)

Primary Outcome

Change in an equivalent of daily calorie consumption for a month before and 3 months after the initiation of home oxygen therapy (HOT)
*An equivalent of daily calorie consumption for a month
= Sum of equivalent of daily calorie consumption divided by the number of physically active days

Secondary Outcome

1) Change over time in an equivalent of daily calorie consumption for each month including before initiation of HOT and after 1,2, and 3 month of HOT.
2) Change over time in a daily step counts and activity time for each month including before initiation of HOT and after 1,2, and 3 month of HOT.
3) Change over time in activity time according to an intensity of physical activity (1.1-1.9METs, 2.0-2.9METs, >= 3.0METs) before initiation of HOT and after 1,2, and 3 month of HOT.
4) Change in physical activity-related and depression-related indices 1 month before and 3 months after the initiation of HOT or at the time of discontinuation.
evaluation item: modified British Medical Research Council (mMRC), COPD assessment test (CAT), Life space assessment (LSA), Hospital Anxiety and Depression Scale (HADS)
5) Change over time in oxygen saturation (SpO2) and pulse rate before initiation of HOT and after 1,2, and 3 month of HOT.
*Evaluation will be in the morning when leaving the bed, during exertion (bathing, evacuation), and at bedtime

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with chronic respiratory failure meeting the criteria for home oxygen therapy
2) Patients over 20 years old
3) Patients who have not been hospitalized for illnesses affecting their activities of daily living (ADL) within the last month

Exclude criteria

1) Patients with cancer (However, patients who have undergone curative treatment and are considered cured are eligible for inclusion)
2) Patients with comorbidities including severe cardiac, psychiatric, and neuromuscular diseases
3) Patients who spend almost the entire day in bed (Performance status is 3 or higher)
4) Inappropriate for the enrolment by the judgement of the principal investigator or the subinvestigators

Related Information

• Primary Sponsor: Tanimura Kazuya
• Source(s) of Monetary Support: FUKUDA LIFE TECH Co., Ltd.,Nara Medical University