DementiaPrAISED2NCT04065854
Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment
A study testing Intervention in people with Dementia and Mild Cognitive Impairment, run by Nottingham University Hospitals NHS Trust at 4 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Mild Cognitive Impairment
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Oct 2018to 13 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
RICE - Research Institute for the Care of Older People
Bath, Somerset, BA1 3NG
Vanessa Bishop, 01225 476420, V.Bishop@bath.ac.uk
Lola Dali-Kemmery, 01225 476420, L.Dali-Kemmery@bath.ac.uk
- Recruiting
Derbyshire Healthcare NHS Foundation Trust
Derby, Derbyshire, DE22 3LZ
Simon Thacker, 01332623683, Simon.thacker@derbyshcft.nhs.uk
Gemma Harrison, 01332623700 ext. 33474, gemma.harrison3@nhs.net
- Recruiting
Lincolnshire Partnership NHS Foundation Trust
Lincoln, Lincolnshire, NG34 8GG
Carol Duff, 01522500690, Carol.Duff@LPFT.nhs.uk
Tracy McCranor, 07795426736, Tracy.McCranor@lpft.nhs.uk
- Recruiting
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Notts, NG3 6AA
Helen Smith, 01158837826, Helen.smith@nottshc.nhs.uk
Kehinde Junaid, 01159560884, Kehinde.Junaid@nottshc.nhs.uk
About this study
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
Read the 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.
- Conditions
- Dementia, Mild Cognitive Impairment
- Being tested
- Intervention
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive standard brief falls assessment and advice. |
| Intervention | Active comparator | Therapy intervention. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 12 months
Secondary outcomes (12)
Nottingham Extended ADL Scale
Self-reported Activities of Daily Living (ADL) using the Nottingham Extended ADL Scale [Nouri and Lincoln 1980].
Measured: 12 months
Falls Rate
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)
Measured: 12 months
Quality of Life
Quality of life (EQ5D3L and EQ5D5L proxy [EuroQol Group 1990]; DemQol and DemQol proxy, including Demqol-u weights [Smith 2005; Mulhern 2013])
Measured: 12 months
Mood or 'Affect'
Mood or 'Affect' - Hospital Anxiety and Depression Scale (HADS [Zigmond and Snaith 1983]; Apathy Evaluation Scale - AES [Marin, Biedrzycki and Firinciogullari 1991])
Measured: 12 months
Physical activity
Longitudinal Aging Study Amsterdam (LASA) physical activity questionnaire [Stel 2004], pedometers
Measured: 12 months
Cognition
three scales from CANTAB [Cambridge Cognition, 2015]; Montreal Cognitive Assessment - MoCA [Nasreddine 2005], verbal fluency (from MoCA)
Measured: 12 months
Time to first fall
Time to first fall (from diary)
Measured: 12 months
Rate of fractures and injurious falls
Rate of fractures and injurious falls (from diary)
Measured: 12 months
Rate of hospital and care home admissions, and days spent in hospital
Rate of hospital and care home admissions, and days spent in hospital (from diary, hospital administrative records)
Measured: 12 months
Carer strain
Carer strain (Carergiver Strain Index [Robinson 1983]).
Measured: 12 months
Carer health-related quality of life
Carer health-related quality of life (EQ5D-5L [EuroQol Group 1990])
Measured: 12 months
Personality
Personality (Big Five Personality Inventory- short [BFI-10, Rammstedt and John 2007])
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Oct 2018
- Primary completion31 Mar 2021 (estimated)
- Study completion13 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065854
- Sponsor's protocol ID
- 17HC006
- Acronym
- PrAISED2
- Status last verified
- Aug 2019
- First submitted
- 21 May 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04065854
- Acronym / sponsor ID
- PrAISED2 / 17HC006
- Conditions
- Dementia, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 13 Mar 2022 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive standard brief falls assessment and advice. |
| Intervention | Active comparator | Behavioral: InterventionTherapy intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAssessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision. | Behavioural | Intervention |
Primary outcome
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 secondary outcomes
Nottingham Extended ADL Scale
Time frame: 12 months
Falls Rate
Time frame: 12 months
Quality of Life
Time frame: 12 months
Mood or 'Affect'
Time frame: 12 months
Physical activity
Time frame: 12 months
Cognition
Time frame: 12 months
Time to first fall
Time frame: 12 months
Rate of fractures and injurious falls
Time frame: 12 months
Rate of hospital and care home admissions, and days spent in hospital
Time frame: 12 months
Carer strain
Time frame: 12 months
Carer health-related quality of life
Time frame: 12 months
Personality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- PrAISED websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Dementia and Mild Cognitive Impairment, run by Nottingham University Hospitals NHS Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Goldberg, PhD (01158230543, Sarah.Goldberg@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability Assessment in Dementia (DAD) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.