Promoting Activity, Independence and Stability in Early Dementia

NCT02874300 | Completed

• 1 other identifier: 16HC001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Disability Assessment in Dementia (Gelinas and Gauthier, 1994)

  This is a feasibility study, so there are no primary outcome measures. However for the definitive trial, the primary outcome measure will be Activities of Daily Living (ADL) measured by the Disability Assessment in Dementia (DAD). The DAD measures functional disability based on the model of health proposed by the World Health Organisation. It consists of 40 questions which assess basic activities of daily living (dressing, hygiene, continence and eating), instrumental activities of daily living (meal preparation, telephoning, housework, taking care of finance, and correspondence, going on an outing, taking medications and ability to stay safely at home) and leisure activities. To understand the cognitive dimensions of disabilities in ADL, the activities are subdivided into initiation, planning and organisation and effective performance. The assessment is administered through an interview with the caregiver.

  1 Year

Secondary Outcomes (1)

• Falls (defined as 'unintentionally coming to rest on the ground or at a lower level, however caused')

  4-12 Months from randomisation

Study Arms (3)

Control

NO INTERVENTION

The control arm will comprise the offer of an assessment by a standard community falls prevention service.

High intensity supervision arm

OTHER

high-intensity supervision

Other: High intensity supervision arm

Moderate intensity supervision arm

OTHER

Moderate intensity supervision

Other: Moderate intensity supervision arm

Interventions

High intensity supervision arm OTHER

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.

High intensity supervision arm

Moderate intensity supervision arm OTHER

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.

Moderate intensity supervision arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age 65 or over (no maximum)
• a diagnosis of dementia or an assessment of MCI (of any subtype), attendance at a memory assessment service, or on the Join Dementia Research register, with a cognitive score in the range defined, with no other apparent cause for cognitive impairment
• Able to walk without human help
• Able to communicate in English.
• Able to see, hear and have dexterity sufficient to perform neuropsychological tests
• Capacity to give consent to participate, and agreeing to do so
• Montreal Cognitive Assessment (MoCA) 15-25 or standardised Mini-mental state examination (sMMSE) 18-26 or Addenbrookes Cognitive Examination (ACE-III) 60-94 .
• Carer participants will be spouses, family members or others in a caring relationship who see the patient participant most weeks, or speaks by telephone most weeks, are willing to take part and can communicate in English.

You may not qualify if:

• Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's or other severe neurological disease)
• Life expectancy of less than 1 year
• Likely to be unable to undertake the intervention regularly (e.g. planned elective surgery, planning to move away or commitments elsewhere).
• Unable to communicate in English.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (3)

• Hartfiel N, Gladman J, Harwood R, Tudor Edwards R. Social Return on Investment of Home Exercise and Community Referral for People With Early Dementia. Gerontol Geriatr Med. 2022 Jun 3;8:23337214221106839. doi: 10.1177/23337214221106839. eCollection 2022 Jan-Dec.

  PMID: 35677674 DERIVED

• Goldberg SE, van der Wardt V, Brand A, Burgon C, Bajwa R, Hoare Z, Logan PL, Harwood RH; PrAISED Study Group. Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial. BMC Geriatr. 2019 Dec 16;19(1):353. doi: 10.1186/s12877-019-1379-5.

  PMID: 31842828 DERIVED

• Harwood RH, van der Wardt V, Goldberg SE, Kearney F, Logan P, Hood-Moore V, Booth V, Hancox JE, Masud T, Hoare Z, Brand A, Edwards RT, Jones C, das Nair R, Pollock K, Godfrey M, Gladman JRF, Vedhara K, Smith H, Orrell M. A development study and randomised feasibility trial of a tailored intervention to improve activity and reduce falls in older adults with mild cognitive impairment and mild dementia. Pilot Feasibility Stud. 2018 Feb 17;4:49. doi: 10.1186/s40814-018-0239-y. eCollection 2018.

  PMID: 29468084 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rowan Harwood, FRCP, MD, MSc, MA, BM, BA

  Consultant physician/geriatrician, Nottingham University Hospitals NHS Trust. Honorary Professor School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: September 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: March 26, 2019
• Last Updated: May 22, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share