Randomized Controlled Trial

. 2025 Mar 3;54(3):afaf053.

doi: 10.1093/ageing/afaf053.

Process evaluation in a randomised controlled trial of DREAMS-START (dementia related manual for sleep; strategies for relatives) for sleep disturbance in people with dementia and their carers

Sarah Amador¹, Gill Livingston^{1

2}, Mariam Adeleke³, Julie Barber³, Lucy Webster¹, Hang Yuan⁴, Sube Banerjee⁵, Ankita Bhojwani¹, Georgina Charlesworth^{6

7}, Christopher Clarke⁸, Caroline Connell⁸, Colin A Espie⁹, Ruochen Gan¹, Lina Gonzalez¹⁰, Rossana Horsley¹¹, Rachael M Hunter¹⁰, Simon D Kyle⁹, Malvika Muralidhar¹, Liam Pikett¹, Malgorzata Raczek¹², Marija Taneska¹, Zuzana Walker^{1

13}, Zuyu Wang¹, Penny Rapaport^{1

2}

Affiliations

¹ University College London, Mental Health of Older People Department, Division of Psychiatry, London W1T 7NF, England, UK.
² Camden and Islington NHS Foundation Trust, London, NW1 0PE, England, UK.
³ University College London, Department of Statistical Science, London, WC1E 6BT, England, UK.
⁴ University of Oxford, Nuffield Department of Population Health, Oxford, OX3 7LF, England, UK.
⁵ University of Nottingham, Faculty of Medicine and Health Sciences, Nottingham, NG7 2UH, England, UK.
⁶ University College London, Division of Psychology and Language Sciences, London, WC1N 1PF, England, UK.
⁷ North East London NHS Foundation Trust, London, RM13 8CQ, England, UK.
⁸ Tees Esk and Wear Valleys NHS Foundation Trust, Darlington, DL2 2TS, England, UK.
⁹ Nuffield Department of Clinical Neurosciences University of Oxford - Sir Jules Thorn Sleep and Circadian Neuroscience Institute, Oxford, OX1 3QU, England, UK.
¹⁰ University College London, Research Department of Primary Care and Population Health, London, NW3 2PF, England, UK.
¹¹ Alzheimer's Society, London, EC3N 2AE, England, UK.
¹² Brighton and Sussex Medical School, Centre for Dementia Studies, Brighton, BN1 9PX, England, UK.
¹³ Essex Partnership University NHS Foundation Trust, Essex, SS11 7XX, England, UK.

PMID: 40116618
PMCID: PMC11926977
DOI: 10.1093/ageing/afaf053

Randomized Controlled Trial

Process evaluation in a randomised controlled trial of DREAMS-START (dementia related manual for sleep; strategies for relatives) for sleep disturbance in people with dementia and their carers

Sarah Amador et al. Age Ageing. 2025.

. 2025 Mar 3;54(3):afaf053.

doi: 10.1093/ageing/afaf053.

Authors

Affiliations

¹ University College London, Mental Health of Older People Department, Division of Psychiatry, London W1T 7NF, England, UK.
² Camden and Islington NHS Foundation Trust, London, NW1 0PE, England, UK.
³ University College London, Department of Statistical Science, London, WC1E 6BT, England, UK.
⁴ University of Oxford, Nuffield Department of Population Health, Oxford, OX3 7LF, England, UK.
⁵ University of Nottingham, Faculty of Medicine and Health Sciences, Nottingham, NG7 2UH, England, UK.
⁶ University College London, Division of Psychology and Language Sciences, London, WC1N 1PF, England, UK.
⁷ North East London NHS Foundation Trust, London, RM13 8CQ, England, UK.
⁸ Tees Esk and Wear Valleys NHS Foundation Trust, Darlington, DL2 2TS, England, UK.
⁹ Nuffield Department of Clinical Neurosciences University of Oxford - Sir Jules Thorn Sleep and Circadian Neuroscience Institute, Oxford, OX1 3QU, England, UK.
¹⁰ University College London, Research Department of Primary Care and Population Health, London, NW3 2PF, England, UK.
¹¹ Alzheimer's Society, London, EC3N 2AE, England, UK.
¹² Brighton and Sussex Medical School, Centre for Dementia Studies, Brighton, BN1 9PX, England, UK.
¹³ Essex Partnership University NHS Foundation Trust, Essex, SS11 7XX, England, UK.

PMID: 40116618
PMCID: PMC11926977
DOI: 10.1093/ageing/afaf053

Abstract

Introduction: DREAMS-START is a multicomponent intervention targeting sleep disturbance in people with dementia. To enhance understanding of the DREAMS-START randomised controlled trial, which showed improved sleep in the intervention compared to the control arm, we conducted a process evaluation exploring (i) DREAMS-START delivery, (ii) behaviour change mechanisms and (iii) contextual factors impacting outcomes.

Methods: Mixed-methods design. We measured intervention adherence, fidelity and additional therapeutic process measures. We interviewed a sub-sample of intervention arm family carers and facilitators delivering DREAMS-START. We analysed data thematically guided by a prespecified theory of change logic model informed by the Theoretical Domains Framework. We measured movement using an actigraph worn by the person with dementia at baseline and at four- and eight-month follow-ups to explore potential mechanisms of action.

Results: Attendance was good (82.8% attended ≥4/6 sessions). Mean fidelity score (95.4%; SD 0.08) and median score for all four process measures assessed (5/5; IQR 5-5) were high. We interviewed 43/188 family carers and 9/49 DREAMS-START facilitators. We identified three overarching themes aligned with our model: (i) knowledge and facilitation enable behaviour change, (ii) increasing sleep pressure and developing skills to manage sleep disturbances and (iii) Establishing a routine and sense of control. We were unable to collect sufficient data for pre-specified actigraphy analyses.

Conclusion: Despite competing demands, carers attended DREAMS-START. It promoted behaviour change through supportive in-session reflection, increasing carer knowledge and skills. This was embedded between sessions and actions were positively reinforced as carers experienced changes. Results will inform future implementation in clinical services.

Keywords: dementia; intervention; multicomponent; older people; process evaluation; sleep disturbance.

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Conflict of interest statement

None.

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References

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Process evaluation in a randomised controlled trial of DREAMS-START (dementia related manual for sleep; strategies for relatives) for sleep disturbance in people with dementia and their carers

Affiliations

Process evaluation in a randomised controlled trial of DREAMS-START (dementia related manual for sleep; strategies for relatives) for sleep disturbance in people with dementia and their carers

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical