{
  "abstract": "Objectives To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.Design Pilot cluster randomised controlled trial (c-RCT).Setting Community-based healthcare services across six UK sites representing primary and secondary care settings.Participants 31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.Interventions The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.Primary and secondary outcome measures Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.Results Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.Conclusions The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.Trial registration number ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).",
  "authors": [
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK"
      ],
      "name": "Leanne Greene"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "James Connors"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK"
      ],
      "name": "Claire Hulme"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK",
        "NIHR ARC South West Peninsula, University of Exeter, Exeter, UK"
      ],
      "name": "Obioha C Ukoumunne"
    },
    {
      "affiliations": [
        "Campus for Ageing and Vitality, Cumbria Northumberland Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK"
      ],
      "name": "Robert Barber"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK"
      ],
      "name": "Alison Bingham"
    },
    {
      "affiliations": [
        "Barts Health & Queen Mary University of London, London, UK"
      ],
      "name": "Simon Conroy"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK"
      ],
      "name": "Chris Fox"
    },
    {
      "affiliations": [
        "Lincolnshire Partnership NHS Foundation Trust, Lincoln, UK"
      ],
      "name": "Carol Duff"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK",
        "NIHR ARC South West Peninsula, University of Exeter, Exeter, UK"
      ],
      "name": "Victoria Goodwin"
    },
    {
      "affiliations": [
        "Centre for Primary Care, Queen Mary University of London Wolfson Institute of Population Health, London, UK",
        "Academic Centre of Healthy Ageing, Barts Health NHS Trust, London, UK"
      ],
      "name": "Adam L Gordon"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK"
      ],
      "name": "Abigail J Hall"
    },
    {
      "affiliations": [
        "University of Nottingham School of Health Sciences, Nottingham, UK",
        "Health Care of Older People, Nottingham University Hospitals NHS Trust, Nottingham, UK"
      ],
      "name": "Rowan H Harwood"
    },
    {
      "affiliations": [
        "Department of Inflammation and Ageing, School of Infection, Inflammation and Immunology, College of Medicine and Health, University of Birmingham, Birmingham, UK",
        "Department of Healthcare for Older People, Queen Elizabeth Hospital Birmingham, Birmingham, UK"
      ],
      "name": "Thomas Jackson"
    },
    {
      "affiliations": [
        "Innovations in Dementia, Exeter, UK"
      ],
      "name": "Rachael Litherland"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK",
        "School of Primary Care, University of Southampton, Southampton, UK"
      ],
      "name": "Sarah Morgan-Trimmer"
    },
    {
      "affiliations": [
        "Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK"
      ],
      "name": "Steve W Parry"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK"
      ],
      "name": "Ashima Sharma"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "Bethany Whale"
    },
    {
      "affiliations": [
        "University of Exeter Medical School, University of Exeter, Exeter, UK"
      ],
      "name": "Louise Allan"
    }
  ],
  "title": "Feasibility of the MAINTAIN intervention to support independence after a fall for people with dementia: a pilot cluster randomised controlled trial in participants’ own homes",
  "uid": "aa7865c2-e816-595c-9cbb-c0210b48fcf8"
}