What is the clinical evidence from this study?

Study design: RCT. Population: heart failure (n=32). Intervention: Non-pharmacological interventions. Primary outcome: Quality of sleep and health-related quality of life (p=0.22-0.40).

November 14, 2018Open Access

Non-pharmacological interventions for sleep and quality of life: a randomized pilot study

Key Result

Non-pharmacological interventions improved sleep and quality of life in heart failure patients, though differences between groups were not statistically significant (p between 0.22 and 0.40).

Study Design

Type

RCT (n=32)

Randomization

randomized

Structured PICO

Do non-pharmacological interventions improve quality of sleep and quality of life in patients with heart failure?

Population

32 patients with heart failure randomized to four groups and followed for 24 weeks to assess sleep and quality of life.

Intervention

Non-pharmacological interventions (assigned to four groups)

Comparator

Other non-pharmacological intervention groups (four groups total)

Outcome

Quality of sleep (assessed using Pittsburgh Sleep Quality Inventory) and health-related quality of life (assessed using Minnesota Living with Heart Failure Questionnaire) at 12th and 24th weekspatient reported

A pilot RCT of non-pharmacological interventions for sleep and quality of life in heart failure patients found no significant differences between groups but provided effect sizes for future confirmatory trials.

Main Result

p-value: p=0.22-0.40

Abstract

OBJECTIVE: to estimate the effects of non-pharmacological interventions to improve the quality of sleep and quality of life of patients with heart failure. METHOD: pilot study of a randomized controlled trial with 32 individuals assigned to four groups. Sleep was assessed using the Pittsburgh Sleep Quality Inventory, while health-related quality of life was assessed using the Minnesota Living with Heart Failure Questionnaire, at the baseline and at the 12th and 24th weeks. The means of the outcomes according to intervention groups were compared using analysis of covariance; effect sizes were calculated per group. RESULTS: all groups experienced improved quality of sleep and health-related quality of life at the end of the intervention (week 12) and at follow-up (week 24), though differences were not statistically significant (p between 0.22 and 0.40). The effects of the interventions at the 12th week ranged between -2.1 and -3.8 for the quality of sleep and between -0.8 and -1.7 for quality of life, with similar values at the 24th week. CONCLUSION: the effects found in this study provide information for sample size calculations and statistical power for confirmatory studies. Brazilian Clinical Trials Registry - RBR 7jd2mm.

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