Promoting Activity, Independence and Stability in Early Dementia

Summary

People with memory problems can struggle with everyday activities and may stop doing things they want to do. They are more prone to accidents and have a higher risk of falling. Occupational therapists can advise how to do daily activities more easily and safely. Physiotherapists can teach exercises which increase activity and improve balance, and may help maintain memory.

There is little research on how to make these interventions work for people with memory problems. The investigators have developed two activity and exercise programmes suitable for people with memory problems. The investigators will study them in a feasibility trial. One programme involves high-intensity supervision (50 visits over one year), the other moderate-intensity supervision (11 visits over three months). The investigators will compare these with standard falls prevention assessment and advice (1-3 therapist visits). The investigators will encourage participants to exercise by themselves or with family members over the year, and once the programme ends.

People with early dementia or memory problems will be eligible for this study. If possible, the investigators will also recruit a family member. Participants will be recruited from memory clinics or the 'Join Dementia Research' register. The intervention will be delivered over a maximum of 1 year in their own homes. Researchers will visit to collect information at baseline and at 12 months. The investigators will measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants will complete weekly falls diaries. Intervention persistence will be measured for 24 months.

The investigators will conduct interviews and discussion groups to help develop the programmes, and understand how they work in practice ('process evaluation'). The investigators will also do initial work on health economic modelling, dissemination and implementation.

Study findings will be used to refine the intervention, and inform a planned definitive randomised controlled trial.

Conditions

• Dementia MCI (Mild Cognitive Impairment)

Interventions

OTHER

High intensity supervision arm

The higher-intensity supervision arm will comprise 6 occupational therapist (OT) home visits and 5 physiotherapist visits (1,1,2,2,6,12,18,24,30,36 and 52) plus supervised support from a rehabilitation support worker (RSW) twice a week for 3 months, once a week for 3 months, once a fortnight for 3 months and once a month for 3 months. Initially, and at review and progression points, the RSW will visit jointly with the therapists.

OTHER

Moderate intensity supervision arm

The moderate-intensity supervision arm will be based on an ongoing Australian trial (83, 112). There will be 6 OT home visits and 5 physiotherapist visits (weeks 1,1,2,3,4,5,6,7,8,10,12) and three OT telephone calls (weeks 9,10,11). Participants will be expected to exercise independently in-between supervised sessions.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Nottingham University Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Rowan Harwood, FRCP, MD, MSc, MA, BM, BA · Consultant physician/geriatrician, Nottingham University Hospitals NHS Trust. Honorary Professor School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2018-03-31

Completion

2019-03-26