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

NCT04065854 | Unknown DMC

• 1 other identifier: 17HC006
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 4

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

Conditions

Dementia; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Disability Assessment in Dementia (DAD)

  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."

  12 months

Secondary Outcomes (12)

• Nottingham Extended ADL Scale

  12 months

• Falls Rate

  12 months

• Quality of Life

  12 months

• Mood or 'Affect'

  12 months

• Physical activity

  12 months

Study Arms (2)

Control

NO INTERVENTION

The control group will receive standard brief falls assessment and advice.

Intervention

ACTIVE COMPARATOR

Therapy intervention.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision.

Intervention

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)
• Diagnosis of MCI or dementia (of any subtype, except Dementia with Lewy Bodies i.e. Parkinson's Disease Dementia)
• 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
• Able to walk without human help
• Able to communicate in English
• Able to see, hear and have dexterity sufficiently to perform neuropsychological tests
• Have capacity to give consent to participate, and consenting to do so

You may not qualify if:

• Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's, Dementia with Lewy Bodies, or other severe neurological disease)
• 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)

Sponsors & Collaborators

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

Study Sites (4)

Derbyshire Healthcare NHS Foundation Trust

Derby, Derbyshire, DE22 3LZ, United Kingdom

RECRUITING

Lincolnshire Partnership NHS Foundation Trust

Lincoln, Lincolnshire, NG34 8GG, United Kingdom

RECRUITING

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Notts, NG3 6AA, United Kingdom

RECRUITING

RICE - Research Institute for the Care of Older People

Bath, Somerset, BA1 3NG, United Kingdom

RECRUITING

Related Links

• PrAISED website

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Sarah Goldberg, PhD

CONTACT

01158230543; Sarah.Goldberg@nottingham.ac.uk

Rowan Harward, PhD

CONTACT

01158230873; Rowan.Harwood@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: August 22, 2019
• Study Start: October 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 13, 2022
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)