- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065854
Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment (PrAISED2)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah Goldberg, PhD
- Phone Number: 01158230543
- Email: Sarah.Goldberg@nottingham.ac.uk
Study Contact Backup
- Name: Rowan Harward, PhD
- Phone Number: 01158230873
- Email: Rowan.Harwood@nottingham.ac.uk
Study Locations
-
-
Derbyshire
-
Derby, Derbyshire, United Kingdom, DE22 3LZ
- Recruiting
- Derbyshire healthcare NHS foundation trust
-
Contact:
- Simon Thacker
- Phone Number: 01332623683
- Email: Simon.thacker@derbyshcft.nhs.uk
-
Contact:
- Gemma Harrison
- Phone Number: 33474 01332623700
- Email: gemma.harrison3@nhs.net
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-
Lincolnshire
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Lincoln, Lincolnshire, United Kingdom, NG34 8GG
- Recruiting
- Lincolnshire partnership NHS foundation trust
-
Contact:
- Carol Duff
- Phone Number: 01522500690
- Email: Carol.Duff@LPFT.nhs.uk
-
Contact:
- Tracy McCranor
- Phone Number: 07795426736
- Email: Tracy.McCranor@lpft.nhs.uk
-
-
Notts
-
Nottingham, Notts, United Kingdom, NG3 6AA
- Recruiting
- Nottinghamshire Healthcare NHS Foundation Trust
-
Contact:
- Helen Smith
- Phone Number: 01158837826
- Email: Helen.smith@nottshc.nhs.uk
-
Contact:
- Kehinde Junaid
- Phone Number: 01159560884
- Email: Kehinde.Junaid@nottshc.nhs.uk
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-
Somerset
-
Bath, Somerset, United Kingdom, BA1 3NG
- Recruiting
- RICE - Research Institute for the Care of Older People
-
Contact:
- Vanessa Bishop
- Phone Number: 01225 476420
- Email: V.Bishop@bath.ac.uk
-
Contact:
- Lola Dali-Kemmery
- Phone Number: 01225 476420
- Email: L.Dali-Kemmery@bath.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
The control group will receive standard brief falls assessment and advice.
|
|
Active Comparator: Intervention
Therapy intervention.
|
Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards.
Tailored adherence support and supervision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability Assessment in Dementia (DAD)
Time Frame: 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." |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nottingham Extended ADL Scale
Time Frame: 12 months
|
Self-reported Activities of Daily Living (ADL) using the Nottingham Extended ADL Scale [Nouri and Lincoln 1980].
|
12 months
|
Falls Rate
Time Frame: 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)
|
12 months
|
Quality of Life
Time Frame: 12 months
|
Quality of life (EQ5D3L and EQ5D5L proxy [EuroQol Group 1990]; DemQol and DemQol proxy, including Demqol-u weights [Smith 2005; Mulhern 2013])
|
12 months
|
Mood or 'Affect'
Time Frame: 12 months
|
Mood or 'Affect' - Hospital Anxiety and Depression Scale (HADS [Zigmond and Snaith 1983]; Apathy Evaluation Scale - AES [Marin, Biedrzycki and Firinciogullari 1991])
|
12 months
|
Physical activity
Time Frame: 12 months
|
Longitudinal Aging Study Amsterdam (LASA) physical activity questionnaire [Stel 2004], pedometers
|
12 months
|
Cognition
Time Frame: 12 months
|
three scales from CANTAB [Cambridge Cognition, 2015]; Montreal Cognitive Assessment - MoCA [Nasreddine 2005], verbal fluency (from MoCA)
|
12 months
|
Time to first fall
Time Frame: 12 months
|
Time to first fall (from diary)
|
12 months
|
Rate of fractures and injurious falls
Time Frame: 12 months
|
Rate of fractures and injurious falls (from diary)
|
12 months
|
Rate of hospital and care home admissions, and days spent in hospital
Time Frame: 12 months
|
Rate of hospital and care home admissions, and days spent in hospital (from diary, hospital administrative records)
|
12 months
|
Carer strain
Time Frame: 12 months
|
Carer strain (Carergiver Strain Index [Robinson 1983]).
|
12 months
|
Carer health-related quality of life
Time Frame: 12 months
|
Carer health-related quality of life (EQ5D-5L [EuroQol Group 1990])
|
12 months
|
Personality
Time Frame: 12 months
|
Personality (Big Five Personality Inventory- short [BFI-10, Rammstedt and John 2007])
|
12 months
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17HC006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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