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Clinical effectiveness of DREAMS START (Dementia Related Manual for Sleep; Strategies for Relatives) versus usual care for people with dementia and their carers: a single-masked, phase 3, parallel-arm, superiority randomised controlled trial
Rapaport P, Amador S, Adeleke MO, Barber JA, Banerjee S, Charlesworth G, et al.. The Lancet Healthy Longevity, 2024-10-01
Topic: Risk, prevention and care in population studies
Plain-language summary
Background Sleep disturbances are common and distressing for people with dementia and their families. Non-pharmacological interventions should be first-line management, avoiding harmful pharmacological side-effects, but there is none with known effectiveness. We aimed to establish whether DREAMS START, a multicomponent intervention, reduced sleep disturbance in people with dementia living at home compared with usual care. Methods We conducted a phase 3, two-arm, multicentre, parallel-arm, superiority randomised controlled trial with masked outcome assessment, recruiting dyads of people with dementia and sleep disturbance and family carers from community settings. Randomisation to the DREAMS START intervention (plus usual treatment) or usual treatment was conducted at dyadic level, blocked, and stratified by site, with a web-based system assigning allocation. DREAMS START is a six-session, manualised intervention delivered face to face or remotely by non-clinically trained graduates over an approximately 3-month period. The primary outcome was sleep disturbance measured by the Sleep Disorders Inventory (SDI) at 8 months. Analyses were on the intention-to-treat population. This trial is registered with ISRCTN 13072268. Findings Between Feb 24, 2021, and March 5, 2023, 377 dyads were randomly assigned (1:1), 189 to usual treatment and 188 to intervention. The mean age of participants with dementia was 79·4 years (SD 9·0), and 206 (55%) were women. The mean SDI score at 8 months was lower in the intervention group compared with the usual treatment group (15·16 [SD 12·77], n=159, vs 20·34 [16·67], n=163]; adjusted difference in means -4·70 [95% CI -7·65 to -1·74], p=0·002). 17 (9%) people with dementia in the intervention group and 17 (9%) in the control group died during the trial; the deaths were unrelated to the intervention. Interpretation To our knowledge, DREAMS START is the first multicomponent intervention to improve the sleep of people living at home with dementia more than usual clinical care. It had sustained effectiveness beyond intervention delivery. The intervention's delivery by non-clinically trained graduates increases the potential for implementation within health services, adding to usual clinical care. Funding National Institute for Health and Care Research Health Technology Assessment.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Rapaport, P., Amador, S., Adeleke, M. O., Barber, J. A., Banerjee, S., Charlesworth, G., et al. (2024). Clinical effectiveness of DREAMS START (Dementia Related Manual for Sleep; Strategies for Relatives) versus usual care for people with dementia and their carers: a single-masked, phase 3, parallel-arm, superiority randomised controlled trial. The Lancet Healthy Longevity. https://doi.org/10.1016/j.lanhl.2024.08.004
Vancouver
Rapaport P, Amador S, Adeleke MO, Barber JA, Banerjee S, Charlesworth G, et al. Clinical effectiveness of DREAMS START (Dementia Related Manual for Sleep; Strategies for Relatives) versus usual care for people with dementia and their carers: a single-masked, phase 3, parallel-arm, superiority randomised controlled trial. The Lancet Healthy Longevity. 2024. doi:10.1016/j.lanhl.2024.08.004. PMID: 39366393.
BibTeX
@article{rapaport2024-39366393,
author = {Rapaport, P. and Amador, S. and Adeleke, M. O. and Barber, J. A. and Banerjee, S. and Charlesworth, G. and others},
title = {{Clinical effectiveness of DREAMS START (Dementia Related Manual for Sleep; Strategies for Relatives) versus usual care for people with dementia and their carers: a single-masked, phase 3, parallel-arm, superiority randomised controlled trial}},
journal = {The Lancet Healthy Longevity},
year = {2024},
doi = {10.1016/j.lanhl.2024.08.004},
pmid = {39366393},
url = {https://doi.org/10.1016/j.lanhl.2024.08.004}
}
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Key findings
- We aimed to establish whether DREAMS START, a multicomponent intervention, reduced sleep disturbance in people with dementia living at home compared with usual care.
- The mean SDI score at 8 months was lower in the intervention group compared with the usual treatment group (15·16 [SD 12·77], n=159, vs 20·34 [16·67], n=163]; adjusted difference in means -4·70 [95% CI -7·65 to -1·74], p=0·002). 17 (9%) people with dementia in the intervention group and 17 (9%) in the control group died during the trial; the deaths were unrelated to the intervention.
Why it matters
In this randomized trial, the DREAMS START intervention reduced sleep disturbance in people with dementia living at home compared with usual care at 8 months. This is a non-drug approach to managing a common symptom, not a treatment for the underlying disease.
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Study details
- Study designRCT
- Participants377
- Effect sizeAdjusted mean difference in Sleep Disorders Inventory at 8 months: -4.70 (95% CI -7.65 to -1.74)
- Evidence strengthHigh
Limitations
Single-country (England) trial; carers could not be masked to allocation and the primary outcome was carer-reported; effect measured at 8 months only.
How this study scored 72/100
Published in a leading specialty journal, and it is a randomized controlled trial. We have no data on free to read, so that was left out: it earned 71 of the 98 points we could judge it on, which is 72 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (The Lancet Healthy Longevity) |
| Journal's citation record | 1 / 4 | The Lancet Healthy Longevity: journal h-index 78 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomized controlled trial |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2024 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 377 participants |
| Effect reported | 3 / 3 | Effect reported with a statistic (interval, p-value, ratio or similar) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 1 / 2 | Randomized (as stated in the record) |
| Times cited | 3 / 7 | Cited 20 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 5.0 citations a year over 4 year(s) since 2024 |
| Impact for its field and year | 4 / 6 | Cited 8.2× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 4 other studies in this library |
| Still being cited | 2 / 4 | Cited 20 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Gill Livingston: h-index 99 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | University of Oxford: institution h-index 2,205 (OpenAlex) |
| Multicenter collaboration | 2 / 3 | OpenAlex lists 8 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 39366393) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 71 / 98 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 71 of the 98 points we could judge it on is 72 out of 100. |
| Total | 72 / 100 | — |
What each of these 20 components measures, and what this score is not →
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