Clinical trial NCT04065854: Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment
Official title: Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2019-08-22
Enrollment: 368
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, pragmatic, parallel-group, randomised controlled trial, with internal pilot trial, and embedded process and economic evaluations.

Web-based randomisation, using a dynamic adaptive algorithm, stratified for centre and other variables to 1) active intervention or 2) standard brief falls assessment and advice. An internal pilot trial will recruit the first 50 participants.
Primary purpose: TREATMENT

Brief summary: A clinical trial to test the clinical and cost-effectiveness of a therapy intervention designed to promote activity and independence and reduce falls, amongst people with early dementia or mild cognitive impairment

Detailed description: Background and study aims 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 with people with memory problems. The aim of this study is to compare an activity and exercise programme developed for people with memory problems to standard falls prevention assessment and advice.

Who can participate? Patients aged 65 or over with early dementia or memory problems, recruited from memory clinics or the 'Join Dementia Research' register

What does the study involve? Participants are randomly allocated to either the control group or the intervention group. The control group receive standard brief falls assessment and advice, and up to two further visits if required. The intervention group receive an assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. The intervention is delivered over 1 year in participants' own homes, and is tailored to individual interests, abilities and need for supervision. Participants are encouraged to exercise by themselves or with family members between visits, and once the programme ends. Researchers visit at the start of the study and after 12 months to measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants complete monthly falls diaries over 15 months. The researchers conduct interviews and video record some therapy sessions to help understand how the programme works in practice.

What are the possible benefits and risks of participating? Some participants may benefit from taking part in the intervention, as exercise is generally known to be beneficial to health and well-being, including benefits to heart, blood pressure, diabetes, joints, mood and daily life. These participants may find that they are better able to do their daily activities. All participants and their relatives may enjoy having the researchers coming to visit them in their house. Some people appreciate having the opportunity to contribute to the well-being of others through research.

Eligibility criteria: Inclusion Criteria:

1. Age 65 or over (no maximum)
2. Diagnosis of MCI or dementia (of any subtype, except Dementia with Lewy Bodies i.e. Parkinson's Disease Dementia)
3. Have a carer or friend who knows the participant well (at least one hour a week contact over the phone, internet, or in person), and is willing and able to act as an informant
4. Able to walk without human help
5. Able to communicate in English
6. Able to see, hear and have dexterity sufficiently to perform neuropsychological tests
7. Have capacity to give consent to participate, and consenting to do so

Exclusion Criteria:

1. Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's, Dementia with Lewy Bodies, or other severe neurological disease)
2. Unavailable over the next year (e.g. plans to relocate or go on a long holiday, or has a life expectancy of less than a year)

Primary outcomes:
measure: Disability Assessment in Dementia (DAD)
timeFrame: 12 months
Secondary outcomes:
measure: Nottingham Extended ADL Scale
timeFrame: 12 months
measure: Falls Rate
timeFrame: 12 months
measure: Quality of Life
timeFrame: 12 months
measure: Mood or 'Affect'
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Cognition
timeFrame: 12 months
measure: Time to first fall
timeFrame: 12 months
measure: Rate of fractures and injurious falls
timeFrame: 12 months
measure: Rate of hospital and care home admissions, and days spent in hospital
timeFrame: 12 months
measure: Carer strain
timeFrame: 12 months
measure: Carer health-related quality of life
timeFrame: 12 months
measure: Personality
timeFrame: 12 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Derbyshire Healthcare NHS Foundation Trust
state: Derbyshire
city: Lincoln
country: United Kingdom
facility: Lincolnshire Partnership NHS Foundation Trust
state: Lincolnshire
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Foundation Trust
state: Notts
city: Bath
country: United Kingdom
facility: RICE - Research Institute for the Care of Older People
state: Somerset
Study officials:
References: