Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Activity based health related actions: Intervention study towards activity, participation and health among older people with risk for health decline, a randomised controlled trial
Acronym
Study hypothesis
The aim of this project is to use a health preventive perspective to identify aspects of what and how activity-based services can best contribute, in the most cost-effective way, to activity and participation aimed ultimately toward sustained health of older people with risk for health decline. The specific aims are reflected in the following research questions:
1. In relation to a control group, what benefits (e.g., person: activity, participation and self-reported health; society: more effective and less costly elderly care) can be identified for older people with risk for health decline receiving activity-based services (individual or group-based) and are the benefits maintained over time?
2. When comparing ordinary societal services, individual activity-based and group activity-based services for older people with risk for health decline, which intervention yields greater benefits for the person and which is most cost-effective?
3. What are the therapeutic mechanisms in the intervention processes that lead to promotion of activity, participation and health among older persons with risk for health decline?
Ethics approval
Ethical Committee in Umea (Sweden) approved (ref: 210-242-32 (M))
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Health decline with older people
Intervention
All three types of activity-focused services (short and longer group- and individual-based) is implemented by an occupational therapist (OT) experienced in working with older people who are experiencing or at risk for problems with performance of and engagement in their daily activities. Briefly, all additional services are focused on health, activity and participation of the older people with risk for health decline and are inspired by the evaluation and intervention principles of the Occupational Therapy Intervention Process Model (OTIPM).
The participants in the individualised activity focused service receive client-centred evaluations and interventions that are activity-based (up to 10 OT contacts over three months).
The group-based activity focused service is also addressing client-centred goals but provided within the group context (10 sessions over 3 months).
The short group-based service is a single meeting with discussions about activity, participation and health.
The two different activity groups are each comprised of approximately six persons in each group. The control group receives ordinary existing societal services but no additional service.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Person's activity level and participation using the Activities of Daily Living (ADL) Taxonomy together with self-rated Modified NPS Interest Checklist (MNPS) that address leisure activities. Measured at base-line, post intervention and at 12 and 24 months follow-up.
Secondary outcome measures
1. Whether changes in activity level and participation influences health, including activity-based well being and loneliness
2. Self-rated health, measured using the 12-item Short Form Health Survey (SF-12)
3. Secondary measure of health measured with the Occupational Well Being Questionnaire
4. Parameters of social aspects of everyday life, evaluated using loneliness scale
5. Health related quality of life measured with the EQ5D
6. Health economic issues such as cost-effectiveness and cost-utility, will be based on relevant costs from a societal perspective (e.g., technical aids, health consumption, costs related to intervention
All measured at baseline, post intervention and at 12 and 24 months follow-up.
Overall trial start date
01/04/2010
Overall trial end date
01/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Older people with risk for health decline, i.e.:
1. Living in ordinary housing
2. Aged 76 - 82 years old, either sex
3. No homecare services
4. Living in an urban area in northern Sweden
The target sample will be identified through the National Tax Board.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
200 persons
Participant exclusion criteria
Persons with clear problems in either cognition and/or communication that would not enable informed consent to participate or ability to participate reliably in self-report
Recruitment start date
01/04/2010
Recruitment end date
01/04/2013
Locations
Countries of recruitment
Sweden
Trial participating centre
Umea University
Umea
SE 901 87
Sweden
Sponsor information
Organisation
Umeå University (Sweden)
Sponsor details
Department of Community Medicine and Rehabilitation &
Ageing and Living Conditions Programme (ALC)
Umea
SE 901 87
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Swedish Research Council (Sweden)
Alternative name(s)
Swedish Research Council, VR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Sweden
Funder name
Carl Wikstroms Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swedish Council for Working Life and Social Research (Sweden)
Alternative name(s)
Swedish Council for Working Life and Social Research, FAS
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Sweden
Funder name
Umea University (Sweden) - IB & CA Branholms Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Erik & Anne-Marie Detlof Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list