Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment

Not Applicable

• Conditions: Dementia; Mild Cognitive Impairment
• Interventions: Behavioral: Intervention

• Registration Number: NCT04065854
• Lead Sponsor: Nottingham University Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-05-21
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-22
• Last Update Posted: 2019-08-22
• Primary Completion: 2021-03-31
• Study Completion: 2022-03-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 368

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	Therapy intervention.

Primary Outcome Measures

Name	Time	Method
Disability Assessment in Dementia (DAD)	12 months	Primary outcomes will be disability in Activities of Daily Living (Disability Assessment in Dementia, DAD) measured 12 months after randomisation. This is as recommended in a recent NIHR systematic review \[Webster 2017\].; scale range is 0% to 100%. Where 0% = minimal functional ability and 100% maximal functional ability. Higher scores represent less disability in ADL and lower scores indicate more dysfunction. There are no subscales.; "The total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated as N/A are not considered for the total score. For example: A score of 33 on 40 (maximum score) converted out of 100 = 83% A score of 33 on 38 (max. score with 2 N/A) converted out of 100 = 87%; This will result in a final score, a percentage which provides an appreciation of global function in ADL. Higher scores represent less disability in ADL while lower scores indicate more dysfunction."

Secondary Outcome Measures

Name	Time	Method
Nottingham Extended ADL Scale	12 months	Self-reported Activities of Daily Living (ADL) using the Nottingham Extended ADL Scale \[Nouri and Lincoln 1980\].
Personality	12 months	Personality (Big Five Personality Inventory- short \[BFI-10, Rammstedt and John 2007\])
Rate of hospital and care home admissions, and days spent in hospital	12 months	Rate of hospital and care home admissions, and days spent in hospital (from diary, hospital administrative records)
Carer health-related quality of life	12 months	Carer health-related quality of life (EQ5D-5L \[EuroQol Group 1990\])
Quality of Life	12 months	Quality of life (EQ5D3L and EQ5D5L proxy \[EuroQol Group 1990\]; DemQol and DemQol proxy, including Demqol-u weights \[Smith 2005; Mulhern 2013\])
Physical activity	12 months	Longitudinal Aging Study Amsterdam (LASA) physical activity questionnaire \[Stel 2004\], pedometers
Cognition	12 months	three scales from CANTAB \[Cambridge Cognition, 2015\]; Montreal Cognitive Assessment - MoCA \[Nasreddine 2005\], verbal fluency (from MoCA)
Rate of fractures and injurious falls	12 months	Rate of fractures and injurious falls (from diary)
Falls Rate	12 months	Falls rate in months four-15 from randomisation (defined as 'unintentionally coming to rest on the ground or at a lower level, however caused', and ascertained by monthly diary)
Time to first fall	12 months	Time to first fall (from diary)
Carer strain	12 months	Carer strain (Carergiver Strain Index \[Robinson 1983\]).
Mood or 'Affect'	12 months	Mood or 'Affect' - Hospital Anxiety and Depression Scale (HADS \[Zigmond and Snaith 1983\]; Apathy Evaluation Scale - AES \[Marin, Biedrzycki and Firinciogullari 1991\])

Trial Locations

Locations (4)

Derbyshire Healthcare NHS Foundation Trust; 🇬🇧 Derby, Derbyshire, United Kingdom

Lincolnshire Partnership NHS Foundation Trust; 🇬🇧 Lincoln, Lincolnshire, United Kingdom

RICE - Research Institute for the Care of Older People; 🇬🇧 Bath, Somerset, United Kingdom

Nottinghamshire Healthcare NHS Foundation Trust; 🇬🇧 Nottingham, Notts, United Kingdom