IMB-NIV program for CHRF
Trial question
What is the role of information-motivation-behavioral skills-based noninvasive ventilation program in patients with chronic hypercapnic respiratory failure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 124
124 patients (67 female, 57 male).
Inclusion criteria: adult patients with chronic hypercapnic respiratory failure and nonadherence to domiciliary noninvasive ventilation.
Key exclusion criteria: known psychiatric disorders except for anxiety and depression; diseases with a life expectancy ≤ 1 year; active malignancy.
Interventions
N=62 IMB-NIV program (a behavioral program using patient empowerment and motivational strategies to improve noninvasive ventilation adherence).
N=62 usual care (regular medical follow-up and education on noninvasive ventilation and problem-solving by nurses).
Primary outcome
Percentage of patients achieving noninvasive ventilation adherence for > 4 hours on > 70% of days at 12 months
61.3%
27.4%
61.3 %
46.0 %
30.6 %
15.3 %
0.0 %
IMB-NIV
program
Usual
care
Significant
increase ▲
NNT = 2
Significant increase in the percentage of patients achieving noninvasive ventilation adherence for > 4 hours on > 70% of days at 12 months (61.3% vs. 27.4%; OR 2.78, 95% CI 1.69 to 4.55).
Secondary outcomes
Significant decrease in Pittsburg Sleep Quality Index score at 12 months (6.23 points vs. 9.58 points; AD -3.87 points, 95% CI -5.45 to -2.29).
Significant increase in Chinese version of the Severe Respiratory Insufficiency Questionnaire summary scale at 12 months (75.16 points vs. 64.25 points; AD 14.62 points, 95% CI 8.67 to 20.56).
Significant decrease in emergency department admissions at 12 months (27 vs. 66; IRR 0.47, 95% CI 0.26 to 0.84).
Conclusion
In adult patients with chronic hypercapnic respiratory failure and nonadherence to domiciliary noninvasive ventilation, IMB-NIV program was superior to usual care with respect to the percentage of patients achieving noninvasive ventilation adherence for > 4 hours on > 70% of days at 12 months.
Reference
Doris Sau Fung Yu, Polly Wai-Chi Li, Jason Chi-Chun Lau et al. Health Communication and Adherence to Noninvasive Ventilation in Chronic Hypercapnic Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451614.
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