TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial

Jayden van Horik; Louise Allan; Aidin Aryankhesal; Niall Broomfield; Peter Greenstreet; Andrea Hilton; Anne Killett; Mizanur Khondoker; Gill Livingston; Yoon Loke; Ian Maidment; Antonieta Medina-Lara; Adam Palmer-Welsh; Joanne Reeve; Sion Scott; Lee Shepstone; Fiona C Warren; Geoff Wong; Chris Fox; on behalf of The TIMES  Programme Team

doi:10.1186/s40814-026-01791-0

TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial

Jayden van Horik
, Louise Allan
, Aidin Aryankhesal
, Niall Broomfield
, Peter Greenstreet
, Andrea Hilton
, Anne Killett
, Mizanur Khondoker
, Gill Livingston
, Yoon Loke
, Ian Maidment
, Antonieta Medina-Lara
, Adam Palmer-Welsh
, Joanne Reeve
, Sion Scott
, Lee Shepstone
, Fiona C Warren
, Geoff Wong
, Chris Fox
, on behalf of The TIMES Programme Team

University of Exeter
University of East Anglia
University of Hull
University College London
University of Oxford

Research output: Contribution to journal › Article › peer-review

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Abstract

BACKGROUND: People living with dementia (PLWD) and mild cognitive impairment (MCI), and their family carers, often experience sleep disturbance which can impair daily living and care. There are limited options for effective long-term pharmacological management of sleep disturbance, yet recent advances in non-pharmacological approaches offer promising alternatives. TIMES is a novel, complex intervention, which aims to improve wellbeing for PLWD/MCI and their carers in primary care, by developing whole-person, tailored care plans that optimise management of sleep disturbance in context.

METHODS: Two-arm cluster-randomised (1:1), single-blinded, feasibility trial in 10 general practice sites in England, recruiting 64 patient-carer dyad participants (32 intervention + 32 treatment as usual). Co-primary objectives are to assess the feasibility and acceptability of conducting a subsequent definitive cluster-randomised controlled trial (cRCT) of the TIMES intervention. Secondary objectives include assessing the ability to collect data to address putative primary and secondary outcomes of a definitive cRCT. We will collect participant demographics at screening, and the following outcome measures at baseline, 9 and 15 week follow-ups: Sleep Disorders Inventory (SDI); Epworth Sleepiness Scale (ESS); Activities of Daily Living assessed with the Disability Assessment for Dementia (ADL DAD); Dementia Quality of Life Measure (DEMQOL); EQ-5D 5 level (EQ-5D-5L); ICEpop Capability measure for older people aged ≥ 65 (ICECAP-O); Neuropsychiatric Inventory Questionnaire (NPI-Q); Client Service Receipt Inventory (CSRI); Telephone Montreal Cognitive Assessment (T-MoCA); patient medical records review; patient serious adverse events (SAEs). We will conduct Process Evaluation interviews and Discrete Choice Experiments to inform refinement of the intervention content and delivery.

DISCUSSION: Our findings will inform the refinement and delivery of a subsequent definitive cRCT that tests the clinical and cost-effectiveness of the TIMES intervention compared with usual care.

TRIAL REGISTRATION: This study received approval from the Health Research Authority (HRA) and London-Harrow Research Ethics Committee (Reference: 24/LO/0123), and is sponsored by the University of Exeter (Reference: 2021-22-38).

TRIAL REGISTRATION: ISRCTN, ISRCTN54051676, registered 20 March 2024, https://www.isrctn.com/ISRCTN54051676.

Original language	English
Article number	48
Journal	Pilot and Feasibility Studies
Volume	12
Issue number	1
Early online date	7 Mar 2026
DOIs	https://doi.org/10.1186/s40814-026-01791-0
Publication status	E-pub ahead of print - 7 Mar 2026

Bibliographical note

Copyright © The Author(s) 2026. This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/

Keywords

Sleep disturbance
Clinical trial
Complex intervention
Primary healthcare
Decision support tool
Tailored care
Dementia
Mild cognitive impairment

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J van Horik et al_Tailored ManagEment of Sleep TIMES for people w dementia and mild cognitive impairment in primary care in England_protocol for a feasibility cluster-randomised controlled
Copyright © The Author(s) 2026. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/
Final published version, 1.23 MBLicence: CC BY 4.0

Cite this

van Horik, J., Allan, L., Aryankhesal, A., Broomfield, N., Greenstreet, P., Hilton, A., Killett, A., Khondoker, M., Livingston, G., Loke, Y., Maidment, I., Medina-Lara, A., Palmer-Welsh, A., Reeve, J., Scott, S., Shepstone, L., Warren, F. C., Wong, G., Fox, C., & Programme Team, O. B. O. T. TIMES. (2026). TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial. Pilot and Feasibility Studies, 12(1), Article 48. Advance online publication. https://doi.org/10.1186/s40814-026-01791-0

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title = "TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial",

abstract = "BACKGROUND: People living with dementia (PLWD) and mild cognitive impairment (MCI), and their family carers, often experience sleep disturbance which can impair daily living and care. There are limited options for effective long-term pharmacological management of sleep disturbance, yet recent advances in non-pharmacological approaches offer promising alternatives. TIMES is a novel, complex intervention, which aims to improve wellbeing for PLWD/MCI and their carers in primary care, by developing whole-person, tailored care plans that optimise management of sleep disturbance in context.METHODS: Two-arm cluster-randomised (1:1), single-blinded, feasibility trial in 10 general practice sites in England, recruiting 64 patient-carer dyad participants (32 intervention + 32 treatment as usual). Co-primary objectives are to assess the feasibility and acceptability of conducting a subsequent definitive cluster-randomised controlled trial (cRCT) of the TIMES intervention. Secondary objectives include assessing the ability to collect data to address putative primary and secondary outcomes of a definitive cRCT. We will collect participant demographics at screening, and the following outcome measures at baseline, 9 and 15 week follow-ups: Sleep Disorders Inventory (SDI); Epworth Sleepiness Scale (ESS); Activities of Daily Living assessed with the Disability Assessment for Dementia (ADL DAD); Dementia Quality of Life Measure (DEMQOL); EQ-5D 5 level (EQ-5D-5L); ICEpop Capability measure for older people aged ≥ 65 (ICECAP-O); Neuropsychiatric Inventory Questionnaire (NPI-Q); Client Service Receipt Inventory (CSRI); Telephone Montreal Cognitive Assessment (T-MoCA); patient medical records review; patient serious adverse events (SAEs). We will conduct Process Evaluation interviews and Discrete Choice Experiments to inform refinement of the intervention content and delivery.DISCUSSION: Our findings will inform the refinement and delivery of a subsequent definitive cRCT that tests the clinical and cost-effectiveness of the TIMES intervention compared with usual care.TRIAL REGISTRATION: This study received approval from the Health Research Authority (HRA) and London-Harrow Research Ethics Committee (Reference: 24/LO/0123), and is sponsored by the University of Exeter (Reference: 2021-22-38).TRIAL REGISTRATION: ISRCTN, ISRCTN54051676, registered 20 March 2024, https://www.isrctn.com/ISRCTN54051676.",

keywords = "Sleep disturbance, Clinical trial, Complex intervention, Primary healthcare, Decision support tool, Tailored care, Dementia, Mild cognitive impairment",

author = "\{van Horik\}, Jayden and Louise Allan and Aidin Aryankhesal and Niall Broomfield and Peter Greenstreet and Andrea Hilton and Anne Killett and Mizanur Khondoker and Gill Livingston and Yoon Loke and Ian Maidment and Antonieta Medina-Lara and Adam Palmer-Welsh and Joanne Reeve and Sion Scott and Lee Shepstone and Warren, \{Fiona C\} and Geoff Wong and Chris Fox and \{Programme Team\}, \{on behalf of The TIMES\}",

note = "Copyright {\textcopyright} The Author(s) 2026. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article{\textquoteright}s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article{\textquoteright}s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/",

year = "2026",

month = mar,

day = "7",

doi = "10.1186/s40814-026-01791-0",

language = "English",

volume = "12",

journal = "Pilot and Feasibility Studies",

issn = "2055-5784",

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van Horik, J, Allan, L, Aryankhesal, A, Broomfield, N, Greenstreet, P, Hilton, A, Killett, A, Khondoker, M, Livingston, G, Loke, Y, Maidment, I, Medina-Lara, A, Palmer-Welsh, A, Reeve, J, Scott, S, Shepstone, L, Warren, FC, Wong, G, Fox, C & Programme Team, OBOTTIMES 2026, 'TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial', Pilot and Feasibility Studies, vol. 12, no. 1, 48. https://doi.org/10.1186/s40814-026-01791-0

TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial. / van Horik, Jayden; Allan, Louise; Aryankhesal, Aidin et al.
In: Pilot and Feasibility Studies, Vol. 12, No. 1, 48, 31.12.2026.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial

AU - van Horik, Jayden

AU - Allan, Louise

AU - Aryankhesal, Aidin

AU - Broomfield, Niall

AU - Greenstreet, Peter

AU - Hilton, Andrea

AU - Killett, Anne

AU - Khondoker, Mizanur

AU - Livingston, Gill

AU - Loke, Yoon

AU - Maidment, Ian

AU - Medina-Lara, Antonieta

AU - Palmer-Welsh, Adam

AU - Reeve, Joanne

AU - Scott, Sion

AU - Shepstone, Lee

AU - Warren, Fiona C

AU - Wong, Geoff

AU - Fox, Chris

AU - Programme Team, on behalf of The TIMES

N1 - Copyright © The Author(s) 2026. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/

PY - 2026/3/7

Y1 - 2026/3/7

N2 - BACKGROUND: People living with dementia (PLWD) and mild cognitive impairment (MCI), and their family carers, often experience sleep disturbance which can impair daily living and care. There are limited options for effective long-term pharmacological management of sleep disturbance, yet recent advances in non-pharmacological approaches offer promising alternatives. TIMES is a novel, complex intervention, which aims to improve wellbeing for PLWD/MCI and their carers in primary care, by developing whole-person, tailored care plans that optimise management of sleep disturbance in context.METHODS: Two-arm cluster-randomised (1:1), single-blinded, feasibility trial in 10 general practice sites in England, recruiting 64 patient-carer dyad participants (32 intervention + 32 treatment as usual). Co-primary objectives are to assess the feasibility and acceptability of conducting a subsequent definitive cluster-randomised controlled trial (cRCT) of the TIMES intervention. Secondary objectives include assessing the ability to collect data to address putative primary and secondary outcomes of a definitive cRCT. We will collect participant demographics at screening, and the following outcome measures at baseline, 9 and 15 week follow-ups: Sleep Disorders Inventory (SDI); Epworth Sleepiness Scale (ESS); Activities of Daily Living assessed with the Disability Assessment for Dementia (ADL DAD); Dementia Quality of Life Measure (DEMQOL); EQ-5D 5 level (EQ-5D-5L); ICEpop Capability measure for older people aged ≥ 65 (ICECAP-O); Neuropsychiatric Inventory Questionnaire (NPI-Q); Client Service Receipt Inventory (CSRI); Telephone Montreal Cognitive Assessment (T-MoCA); patient medical records review; patient serious adverse events (SAEs). We will conduct Process Evaluation interviews and Discrete Choice Experiments to inform refinement of the intervention content and delivery.DISCUSSION: Our findings will inform the refinement and delivery of a subsequent definitive cRCT that tests the clinical and cost-effectiveness of the TIMES intervention compared with usual care.TRIAL REGISTRATION: This study received approval from the Health Research Authority (HRA) and London-Harrow Research Ethics Committee (Reference: 24/LO/0123), and is sponsored by the University of Exeter (Reference: 2021-22-38).TRIAL REGISTRATION: ISRCTN, ISRCTN54051676, registered 20 March 2024, https://www.isrctn.com/ISRCTN54051676.

AB - BACKGROUND: People living with dementia (PLWD) and mild cognitive impairment (MCI), and their family carers, often experience sleep disturbance which can impair daily living and care. There are limited options for effective long-term pharmacological management of sleep disturbance, yet recent advances in non-pharmacological approaches offer promising alternatives. TIMES is a novel, complex intervention, which aims to improve wellbeing for PLWD/MCI and their carers in primary care, by developing whole-person, tailored care plans that optimise management of sleep disturbance in context.METHODS: Two-arm cluster-randomised (1:1), single-blinded, feasibility trial in 10 general practice sites in England, recruiting 64 patient-carer dyad participants (32 intervention + 32 treatment as usual). Co-primary objectives are to assess the feasibility and acceptability of conducting a subsequent definitive cluster-randomised controlled trial (cRCT) of the TIMES intervention. Secondary objectives include assessing the ability to collect data to address putative primary and secondary outcomes of a definitive cRCT. We will collect participant demographics at screening, and the following outcome measures at baseline, 9 and 15 week follow-ups: Sleep Disorders Inventory (SDI); Epworth Sleepiness Scale (ESS); Activities of Daily Living assessed with the Disability Assessment for Dementia (ADL DAD); Dementia Quality of Life Measure (DEMQOL); EQ-5D 5 level (EQ-5D-5L); ICEpop Capability measure for older people aged ≥ 65 (ICECAP-O); Neuropsychiatric Inventory Questionnaire (NPI-Q); Client Service Receipt Inventory (CSRI); Telephone Montreal Cognitive Assessment (T-MoCA); patient medical records review; patient serious adverse events (SAEs). We will conduct Process Evaluation interviews and Discrete Choice Experiments to inform refinement of the intervention content and delivery.DISCUSSION: Our findings will inform the refinement and delivery of a subsequent definitive cRCT that tests the clinical and cost-effectiveness of the TIMES intervention compared with usual care.TRIAL REGISTRATION: This study received approval from the Health Research Authority (HRA) and London-Harrow Research Ethics Committee (Reference: 24/LO/0123), and is sponsored by the University of Exeter (Reference: 2021-22-38).TRIAL REGISTRATION: ISRCTN, ISRCTN54051676, registered 20 March 2024, https://www.isrctn.com/ISRCTN54051676.

KW - Sleep disturbance

KW - Clinical trial

KW - Complex intervention

KW - Primary healthcare

KW - Decision support tool

KW - Tailored care

KW - Dementia

KW - Mild cognitive impairment

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DO - 10.1186/s40814-026-01791-0

M3 - Article

C2 - 41792826

SN - 2055-5784

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JO - Pilot and Feasibility Studies

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ER -

TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial

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