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The clinical, social and cost effectiveness of a decision support tool to optimise community-based tailored management of sleep (TIMES) for people living with dementia or mild cognitive impairment and sleep disturbance

Tailored Management of Sleep (TIMES) for people living with dementia or mild cognitive impairment (MCI) in the community who experience sleep difficulties.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN54015716
Enrollment
290
Registered
2022-08-05
Start date
2022-09-01
Completion date
Unknown
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementias and Neurodegeneration Mental and Behavioural Disorders

Interventions

Our research design uses 3 data collection methods to enable us to explore the depth and breadth of the topic: 1. Intial ethnographic work allows us to study (observe) in depth the pre

Sponsors

University of Exeter
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ethnographic work: 1. GP Surgeries: We are aiming to recruit 6 sites in England with a purposeful target to work with one urban and one rural surgery, a single practice and a practice that is part of a network. When selecting GP surgeries, we will be mindful of population demographics and ethnicity to ensure we have an inclusive sample representation. The CRN will facilitate us in screening, approaching and recruiting GP sites. 2. Participants: Inclusion criteria for health professionals taking part in the ethnographic work is that they work within one of the collaborating GP sites and can provide fully informed consent for consultations to be observed. The inclusion criteria for patients is that they can provide informed consent/consultee assent for observations to be observed. Focus Groups 3. Healthcare professionals: Any healthcare professional working in a participating GP site can take part in the focus groups (e.g. GP, nurse, pharmacist, dietitian physician associate). 4. PLWD/MCI: Individuals with a diagnosis of dementia or MCI who have been allocated a relevant ICD-10 SNOMED code. 5. Carers: Recruited through snowballing via PLWD/MCI participants. There will be no exclusion for gender, age or ethnicity for healthcare professionals or PLWD/MCI/carers. Survey 6. We seek responses from any healthcare professionals (doctors, nurses, pharmacists, nurse associates, physician associates) who would deliver tailored primary care within the UK. We will use our existing network of professional contacts, including the Society Academic Primary Care partners, to distribute our invitation and the link to our survey widely. There will be no exclusion for gender, age or ethnicity.

Exclusion criteria

Exclusion criteria: 1. Ethnographic work: Observations with patients under 18 years of age. 2. Focus groups: Non-English speakers and formal carers in receipt of payment for their work. 3. Survey: Healthcare professionals outside the UK

Design outcomes

Primary

MeasureTime frame
1. Clinicians' understanding of the value, nature and impact of tailored healthcare, for PLWD and MCI, measured using qualitative interviews 2. How tailored care fits into individual and collective everyday practice (if at all), measured using qualitative interviews 3. Factors/resources that enable or prevent the delivery of tailored care to PLWD and MCI (exploring Data, Explanation and Trust whilst also remaining open to other concepts), measured using qualitative interviews 4. Whether clinicians learn from and develop their practice, measured using qualitative interviews Analysis: We will examine the generalisability of observational and focus group findings through a study-bespoke version of the NoMAD tool (theoretically derived 23-item instrument for assessing implementation processes of NPT-informed practice). NoMAD assesses anticipated and actual barriers to implementation by describing participants’ views about how an intervention impacts on work, and expectations about whether it could become a routine part of daily activity. We will use inductive analysis to generate themes representing barriers and enablers to tailored sleep management. Themes will be mapped to NPT concepts to describe how, based on observation of current practice, tailored sleep management may be achieved in context.

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026