Dataset Information

Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial.

ABSTRACT: Objective: Previous research indicates that pain treatment may improve sleep among nursing home patients. We aimed to investigate the long-term effect of pain treatment on 24-h sleep patterns in patients with comorbid depression and dementia. Design: A 13-week, multicenter, parallel-group, double-blind, placebo-controlled randomized clinical trial conducted between August 2014 and September 2016. Setting: Long-term patients from 47 nursing homes in Norway. Participants: We included 106 patients with comorbid dementia and depression according to the Mini Mental Status Examination (MMSE) and the Cornell Scale for Depression in Dementia (CSDD).Intervention: Patients who were not using analgesics were randomized to receive either paracetamol (3 g/day) or placebo tablets. Those who already received pain treatment were randomized to buprenorphine transdermal system (maximum 10 ?g/h/7 days) or placebo transdermal patches. Measurements: Sleep was assessed continuously for 7 days by actigraphy, at baseline and in week 13. Total sleep time (TST), sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), early morning awakening (EMA), and number of wake bouts (NoW) were evaluated. In addition, daytime total sleep time (DTS) was estimated. Pain was assessed with Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale (MOBID-2). Results: The linear mixed model analyses for TST, SE, SOL, WASO, EMA, NoW and DTS showed no statistically significant differences between patients who received active pain treatment and those who received placebo. Post hoc subgroup analyses showed that there were no statistically significant differences between active treatment and placebo from baseline to week 13 in patients who were in pain (MOBID-2 ? 3) at baseline, or in patients who had poor sleep (defined as SE < 85%) at baseline. Patients who received active buprenorphine showed an increase in TST and SE compared to those who received active paracetamol. Conclusion: The main analyses showed that long-term pain treatment did not improve sleep as measured with actigraphy. Compared to paracetamol, TST and SE increased among patients who received buprenorphine. This could indicate that some patients had beneficial effects from the most potent pain treatment. However, based on the present findings, long-term pain treatment is not recommended as a strategy to improve sleep. Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02267057.

SUBMITTER: Blytt KM

PROVIDER: S-EPMC5816805 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial.

Blytt Kjersti M KM Husebo Bettina B Flo Elisabeth E Bjorvatn Bjørn B

Frontiers in psychology 20180213

Objective: Previous research indicates that pain treatment may improve sleep among nursing home patients. We aimed to investigate the long-term effect of pain treatment on 24-h sleep patterns in patients with comorbid depression and dementia. Design: A 13-week, multicenter, parallel-group, double-blind, placebo-controlled randomized clinical trial conducted between August 2014 and September 2016. Setting: Long-term patients from 47 nursing homes in Norway. Participants:</ ...[more]

PMID: 29487556

Similar Datasets

Project description:Objective: Previous research suggests a positive association between pain, depression and sleep. In this study, we investigate how sleep correlates with varying levels of pain and depression in nursing home (NH) patients with dementia. Materials and methods: Cross-sectional study (n = 141) with sleep-related data, derived from two multicenter studies conducted in Norway. We included NH patients with dementia according to the Mini-Mental State Examination (MMSE ≤ 20) from the COSMOS trial (n = 46) and the DEP.PAIN.DEM trial (n = 95) whose sleep was objectively measured with actigraphy. In the COSMOS trial, NH patients were included if they were ≥65 years of age and with life expectancy >6 months. In the DEP.PAIN.DEM trial, patients were included if they were ≥60 years and if they had depression according to the Cornell Scale for Depression in Dementia (CSDD ≥ 8). In both studies, pain was assessed with the Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale (MOBID-2), and depression with CSDD. Sleep parameters were total sleep time (TST), sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), early morning awakening (EMA), daytime total sleep time (DTS) and time in bed (TiB). We registered use of sedatives, analgesics, opioids and antidepressants from patient health records and adjusted for these medications in the analyses. Results: Mean age was 86.2 years and 76.3% were female. Hierarchical regressions showed that pain was associated with higher TST and SE (p < 0.05), less WASO (p < 0.01) and more DTS (p < 0.01). More severe dementia was associated with more WASO (p < 0.05) and TiB (p < 0.01). More severe depression was associated with less TST (p < 0.05), less DTS (p < 0.01) and less TiB (p < 0.01). Use of sedative medications was associated with less TiB (p < 0.05). Conclusion: When sleep was measured with actigraphy, NH patients with dementia and pain slept more than patients without pain, in terms of higher total sleep time. Furthermore, their sleep efficiency was higher, indicating that the patients had more sleep within the time they spent in bed. Patients with more severe dementia spent more time awake during the time spent in bed. Furthermore, people with more severe depression slept less at daytime and had less total sleep time Controlling for concomitant medication use did not affect the obtained results.

Project description:BackgroundUp to 70% of nursing home patients with dementia suffer from sleep problems. Light is the main zeitgeber to the circadian system and thus has a fundamental impact on sleep-wake behaviour. Low indoor light levels in nursing homes have been reported, and in combination with age-related reductions in light sensitivity, insufficient light exposure is likely to contribute to sleep problems in this population. Increasing daytime light exposure using bright light treatment (BLT) may represent a feasible non-pharmacological treatment for sleep problems in nursing home patients with dementia.MethodsThe present study reports on sleep outcomes, which are the primary outcomes of the DEM.LIGHT trial (Therapy Light Rooms for Nursing Home Patients with Dementia- Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems), a 24-week cluster-randomised placebo-controlled trial including 8 nursing home units and 69 resident patients. The intervention comprised ambient light of 1000 lx and 6000 K from 10:00 to 15:00, with gradually increasing and decreasing light levels prior to and following this interval, using ceiling mounted light-fixtures and light emitting diode technology. The placebo condition had continuous standard light levels (150-300 lx, ~ 3000 K). Sleep was assessed at baseline and follow-up at week 8, 16, and 24, using the proxy-rated Sleep Disorder Inventory (SDI) and actigraphy (Actiwatch II, Philips Respironics). Mixed linear models were used to evaluate intervention effects, adjusting for relevant covariates such as age, gender, number of drugs, severity of dementia, eye disease, and estimated light exposure.ResultsSleep as measured by the SDI was significantly improved in the intervention group compared to the control group from baseline to week 16 (B = - 0.06, 95% CI -0.11 - -0.01, p < .05) and from baseline to week 24 (B = - 0.05, 95% CI -0.10 - -0.01, p < .05). There was no effect according to the SDI at week 8 and no significant effects in terms of actigraphically measured sleep.ConclusionsProxy-rated sleep improved among nursing home patients with dementia following 16 and 24 weeks of BLT. These improvements were not corroborated by actigraphy recordings.Trial registrationClinicalTrials.gov Identifier: NCT03357328 . Registered 29 November 2017 - Retrospectively registered.

Project description:BACKGROUND/AIMS:Ensuring fidelity to a behavioral intervention implemented in nursing homes requires awareness of the unique considerations of this setting for research. The purpose of this article is to describe the goals of care cluster-randomized trial and the methods used to monitor and promote fidelity to a goals of care decision aid intervention delivered in nursing homes. METHODS:The cluster randomized trial tested whether a decision aid for goals of care in advanced dementia could improve (1) the quality of communication and decision-making, (2) the quality of palliative care, and (3) the quality of dying for nursing home residents with advanced dementia. In 11 intervention nursing homes, family decision-makers for residents with advanced dementia received a two-component intervention: viewing a video decision aid about goals of care choices and then participating in a structured decision-making discussion with the nursing home care plan team, ideally within 3?months after the decision aid was viewed. Following guidelines from the National Institutes of Health Behavior Change Consortium, fidelity was assessed in study design, in nursing home staff training for intervention implementation, and in monitoring and receipt of the intervention. We also monitored the content and timing of goals of care discussions. RESULTS:Investigators enrolled 151 family decision-maker/resident dyads in intervention sites; of those, 136 (90%) received both components of the intervention, and 92%-99% of discussions addressed each of four recommended content areas-health status, goals of care, choice of a goal, and treatment planning. A total of 94 (69%) of the discussions between family decision-makers and the nursing home care team were completed within 3?months. CONCLUSION:The methods we used for intervention fidelity allowed nursing home staff to implement a goals of care decision aid intervention for advanced dementia. Key supports for implementation included design features that aligned with nursing home practice, efficient staff training, and a structured guide for goals of care discussions between family decision-makers and staff. These approaches may be used to promote fidelity to behavioral interventions in future clinical trials.

Dataset Information

Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial.

Publications

Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets