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Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment (PrAISED2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065854
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Dementia Mild Cognitive Impairment Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
No Intervention: Control
The control group will receive standard brief falls assessment and advice.
Active Comparator: Intervention
Therapy intervention.
Behavioral: Intervention
Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision.




Primary Outcome Measures :
  1. 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."



Secondary Outcome Measures :
  1. 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].

  2. 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)

  3. 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])

  4. 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])

  5. Physical activity [ Time Frame: 12 months ]
    Longitudinal Aging Study Amsterdam (LASA) physical activity questionnaire [Stel 2004], pedometers

  6. Cognition [ Time Frame: 12 months ]
    three scales from CANTAB [Cambridge Cognition, 2015]; Montreal Cognitive Assessment - MoCA [Nasreddine 2005], verbal fluency (from MoCA)

  7. Time to first fall [ Time Frame: 12 months ]
    Time to first fall (from diary)

  8. Rate of fractures and injurious falls [ Time Frame: 12 months ]
    Rate of fractures and injurious falls (from diary)

  9. 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)

  10. Carer strain [ Time Frame: 12 months ]
    Carer strain (Carergiver Strain Index [Robinson 1983]).

  11. Carer health-related quality of life [ Time Frame: 12 months ]
    Carer health-related quality of life (EQ5D-5L [EuroQol Group 1990])

  12. Personality [ Time Frame: 12 months ]
    Personality (Big Five Personality Inventory- short [BFI-10, Rammstedt and John 2007])



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065854


Contacts
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Contact: Sarah Goldberg, PhD 01158230543 Sarah.Goldberg@nottingham.ac.uk
Contact: Rowan Harward, PhD 01158230873 Rowan.Harwood@nottingham.ac.uk

Locations
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United Kingdom
Derbyshire Healthcare NHS Foundation Trust Recruiting
Derby, Derbyshire, United Kingdom, DE22 3LZ
Contact: Simon Thacker    01332623683    Simon.thacker@derbyshcft.nhs.uk   
Contact: Gemma Harrison    01332623700 ext 33474    gemma.harrison3@nhs.net   
Lincolnshire Partnership NHS Foundation Trust Recruiting
Lincoln, Lincolnshire, United Kingdom, NG34 8GG
Contact: Carol Duff    01522500690    Carol.Duff@LPFT.nhs.uk   
Contact: Tracy McCranor    07795426736    Tracy.McCranor@lpft.nhs.uk   
Nottinghamshire Healthcare NHS Foundation Trust Recruiting
Nottingham, Notts, United Kingdom, NG3 6AA
Contact: Helen Smith    01158837826    Helen.smith@nottshc.nhs.uk   
Contact: Kehinde Junaid    01159560884    Kehinde.Junaid@nottshc.nhs.uk   
RICE - Research Institute for the Care of Older People Recruiting
Bath, Somerset, United Kingdom, BA1 3NG
Contact: Vanessa Bishop    01225 476420    V.Bishop@bath.ac.uk   
Contact: Lola Dali-Kemmery    01225 476420    L.Dali-Kemmery@bath.ac.uk   
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Additional Information:
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04065854    
Other Study ID Numbers: 17HC006
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders