Evaluation of a person-centred multidimensional interdisciplinary rehabilitation program for community dwelling older people with dementia and their informal primary caregivers

• Register: ISRCTN
• Last refreshed on: 22 January 2024
• Main ID: ISRCTN59155421
• Date of registration: 04/11/2015
• Prospective Registration: Yes
• Primary sponsor: Umeå University
• Public title: Evaluation of a person-centred multidimensional interdisciplinary rehabilitation program for community dwelling older people with dementia and their informal primary caregivers
• Scientific title: A person-centred Multidimensional InterDisciplinary REhabilitation program for community dwelling older people with Dementia and their informal primary caregivers: a randomised controlled trial
• Date of first enrolment: 04/11/2015
• Target sample size: 179
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN59155421
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Håkan Littbrand

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria for participants with dementia:
1. Diagnosis of dementia according to ICD-10
2. 60 years and older
3. Living in independent housing
4. Expected survival time more than 6 months
5. A Mini-Mental State Examination score of 10 or more
6. Ability to stand up from a chair with armrests with help of no more than one person
7. Able to hear and understand Swedish language sufficiently well to participate in the assessments
8. Move to residential care facilities are not initiated
9. Approval from the participants physician

Inclusion criteria for informal primary caregivers:
Individuals responsible for the care and support of the participant with dementia. A maximum of two people responsible for the care and support of each participant with dementia will be offered to participate in the study. Informal primary caregivers can be people within the family or relatives and other people such as neighbors or friends who help the participant with dementia.
Exclusion criteria: Failure to meet inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia
Mental and Behavioural Disorders
Dementia

Intervention(s)

The person with dementia and informal primary caregivers are randomised, with a 1:1 allocation, to a control group (usual care) or a person-centred multidimensional interdisciplinary rehabilitation program for the person with dementia, including education and support to informal primary caregivers.

Interventions in the rehabilitation program are conducted in appropriate rehabilitation facilities at the Geriatric Centre, University Hospital of Umeå and, when necessary, activities are conducted in the home of the person with dementia and in the community. The interdisciplinary team includes physicians, nurses, physiotherapists, occupational therapists, social workers, dieticians, neuropsychologists, dental hygienists, and pharmacists. The person with dementia is assessed to identify problems and needs within the following 10 potential problem areas:
1. Functional capacity
2. Cognitive function
3. ADL performance
4. Falls
5. Participation in the society
6. Physical activity
7. Nutrition
8. Medical conditions
9. Behavioral and psychological symptoms in dementia
10. Drugs
Based on the findings/problem areas, needs as well as resources and strengths of each individual, the team is composed. The team members, together with the person with dementia and informal primary caregivers, set up individual rehabilitation goals, including specific interventions based on the goals.
The social worker assesses the need for support and counselling through interviews with primary caregivers.

The persons with dementia are offered a rehabilitation period of 16 weeks containing:
1. Physical activity interventions: individual physical exercise twice a week for approximately 45 minutes, supervised by a physiotherapist, with the goal to improve muscle strength, balance and gait ability, as wel

Primary Outcome(s)

Proportion of people with dementia who are still living at home, which is the inverse of death or institutionalisation combined (describes the odds of someone being alive and in their home at a point in time), at the 24 and 36 month follow-up assessment.

Secondary Outcome(s)

Persons with dementia:
1. Depressive symptoms measured using the Geriatric Depression Scale (GDS-15) at 4, 12, 24 and 36 months
2. Psychological well-being measured using the Philadelphia Geriatric Center Morale Scale (PGCMS) at 4, 12, 24 and 36 months
3. Participation in society determined using questions concerning number of visits in the home, number of visits made to others and contacts with relatives and friends using telephone or other media at 4, 12, 24 and 36 months
4. Physical activity measured using the International Physical Activity Questionnaire–Elderly (IPAQ-E) including questions added by the project members at 4, 12, 24 and 36 months
5. Cognitive function measured using the Mini-Mental State Examination (MMSE) and Verbal fluency questionnaire at 4, 12, 24 and 36 months
6. Functional capacity measured using the Berg Balance Scale, chair-stand test, and gait speed test over 2.4 meters at 4, 12, 24 and 36 months
7. ADL performance measured using Functional Independence Measure (FIM), Lawton and Brody's Physical Self-Maintenance Scale (P- and I-ADL) at 4, 12, 24 and 36 months
8. BPSD measured using the Neuropsychiatric Inventory (NPI) at 4, 12, 24 and 36 months
9. Nutritional status measured using the Mini Nutritional Assessment (MNA) at 4, 12, 24 and 36 months
10. Inappropriate drugs including interactions determined using recommendations by The National Board of Health and Welfare in Sweden at 4, 12, 24 and 36 months
11. Feasibility of the intervention by qualitative interviews at the end of the rehabilitation period of people with dementia and informal primary caregivers concerning the experiences of participating in the intervention, and by registering the attendance during the rehabilitation period and adverse events
12. Cost-effectiveness using health related quality of life assessed with the EQ-5D, as well as calculations based on costs of the intervention and consumption of health and social services
13. Explanatory analyses of the feasibility and effects of the intervention. Independent variables: sex, age, access to spousal caregiver, cognitive function, ADL performance, presence of BPSD, nutritional status, and drug use
14. Oral health measured using The Geriatric Oral Health Assessment Index (GOHAI) and Revised Oral Assessment Guide (ROAG) at 4, 12, 24 and 36 months (added 02/02/2016)

Informal primary caregivers:
1. Caregiver burden measured using the Caregiver Burden Scale at 4, 12, 24 and 36 months
2. Depressive symptoms measured using the Geriatric Depression Scale (GDS-15) at 4, 12, 24 and 36 months
3. Health related quality of life assessed measured using the Short Form (36) Health Survey at 4, 12, 24 and 36 months

Secondary ID(s)

N/A

Source(s) of Monetary Support

Forte – Swedish Research Council for Health, Working Life and Welfare (Forskningsrådet om Hälsa, Arbetsliv och Välfärd), The Swedish Dementia Association, The County Council of Västerbotten (local ALF), Umeå University (Umeå Universitet)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Regional Ethical Review Board in Umeå (Sweden), 20/10/2015, ref: 2015-292-31M

Results

• Results available: Yes
• Date Completed: 25/02/2019