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Promoting Activity, Independence and Stability in Early Dementia (PrAISED)

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ClinicalTrials.gov Identifier: NCT02874300
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

Brief Summary:

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 people with memory problems. The investigators have developed two activity and exercise programmes suitable for people with memory problems. The investigators will study them in a feasibility trial. One programme involves high-intensity supervision (50 visits over one year), the other moderate-intensity supervision (11 visits over three months). The investigators will compare these with standard falls prevention assessment and advice (1-3 therapist visits). The investigators will encourage participants to exercise by themselves or with family members over the year, and once the programme ends.

People with early dementia or memory problems will be eligible for this study. If possible, the investigators will also recruit a family member. Participants will be recruited from memory clinics or the 'Join Dementia Research' register. The intervention will be delivered over a maximum of 1 year in their own homes. Researchers will visit to collect information at baseline and at 12 months. The investigators will measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants will complete weekly falls diaries. Intervention persistence will be measured for 24 months.

The investigators will conduct interviews and discussion groups to help develop the programmes, and understand how they work in practice ('process evaluation'). The investigators will also do initial work on health economic modelling, dissemination and implementation.

Study findings will be used to refine the intervention, and inform a planned definitive randomised controlled trial.


Condition or disease Intervention/treatment Phase
Dementia MCI (Mild Cognitive Impairment) Other: High intensity supervision arm Other: Moderate intensity supervision arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Activity, Independence and Stability in Early Dementia
Study Start Date : September 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
No Intervention: Control
The control arm will comprise the offer of an assessment by a standard community falls prevention service.
High intensity supervision arm
high-intensity supervision
Other: High intensity supervision arm
The higher-intensity supervision arm will comprise 6 occupational therapist (OT) home visits and 5 physiotherapist visits (1,1,2,2,6,12,18,24,30,36 and 52) plus supervised support from a rehabilitation support worker (RSW) twice a week for 3 months, once a week for 3 months, once a fortnight for 3 months and once a month for 3 months. Initially, and at review and progression points, the RSW will visit jointly with the therapists.

Moderate intensity supervision arm
Moderate intensity supervision
Other: Moderate intensity supervision arm
The moderate-intensity supervision arm will be based on an ongoing Australian trial (83, 112). There will be 6 OT home visits and 5 physiotherapist visits (weeks 1,1,2,3,4,5,6,7,8,10,12) and three OT telephone calls (weeks 9,10,11). Participants will be expected to exercise independently in-between supervised sessions.




Primary Outcome Measures :
  1. Disability Assessment in Dementia (Gelinas and Gauthier, 1994) [ Time Frame: 1 Year ]

    This is a feasibility study, so there are no primary outcome measures. However for the definitive trial, the primary outcome measure will be Activities of Daily Living (ADL) measured by the Disability Assessment in Dementia (DAD).

    The DAD measures functional disability based on the model of health proposed by the World Health Organisation. It consists of 40 questions which assess basic activities of daily living (dressing, hygiene, continence and eating), instrumental activities of daily living (meal preparation, telephoning, housework, taking care of finance, and correspondence, going on an outing, taking medications and ability to stay safely at home) and leisure activities. To understand the cognitive dimensions of disabilities in ADL, the activities are subdivided into initiation, planning and organisation and effective performance.

    The assessment is administered through an interview with the caregiver.



Secondary Outcome Measures :
  1. Falls (defined as 'unintentionally coming to rest on the ground or at a lower level, however caused') [ Time Frame: 4-12 Months from randomisation ]
    Falls will be measured by a self-completed calendar, returned every month. Telephone calls will prompt the return of the diary.



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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. a diagnosis of dementia or an assessment of MCI (of any subtype), attendance at a memory assessment service, or on the Join Dementia Research register, with a cognitive score in the range defined, with no other apparent cause for cognitive impairment
  3. Able to walk without human help
  4. Able to communicate in English.
  5. Able to see, hear and have dexterity sufficient to perform neuropsychological tests
  6. Capacity to give consent to participate, and agreeing to do so
  7. Montreal Cognitive Assessment (MoCA) 15-25 or standardised Mini-mental state examination (sMMSE) 18-26 or Addenbrookes Cognitive Examination (ACE-III) 60-94 .

Carer participants will be spouses, family members or others in a caring relationship who see the patient participant most weeks, or speaks by telephone most weeks, are willing to take part and can communicate in English.

Exclusion Criteria:

  1. Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's or other severe neurological disease)
  2. Life expectancy of less than 1 year
  3. Likely to be unable to undertake the intervention regularly (e.g. planned elective surgery, planning to move away or commitments elsewhere).
  4. Unable to communicate in English.

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): NCT02874300


Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Rowan Harwood, FRCP, MD, MSc, MA, BM, BA Consultant physician/geriatrician, Nottingham University Hospitals NHS Trust. Honorary Professor School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02874300    
Other Study ID Numbers: 16HC001
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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