Activity based health related actions: Intervention study towards activity, participation and health among older people with risk for health decline

ISRCTN	ISRCTN44231162
DOI	https://doi.org/10.1186/ISRCTN44231162
Secondary identifying numbers	N/A

Submission date: 29/10/2010
Registration date: 15/03/2011
Last edited: 15/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ingeborg Nilsson
Scientific

Umea University
Department of Community Medicine and Rehabilitation &
Ageing and Living Conditions Programme (ALC)
Umea
SE 901 87
Sweden

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethical Committee in Umea (Sweden) approved (ref: 210-242-32 (M))
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2010
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	200 persons
Key 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.
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

Sweden

Study participating centre

Umea University

Umea
SE 901 87
Sweden

Sponsor information

Umeå University (Sweden)
University/education

Department of Community Medicine and Rehabilitation &
Ageing and Living Conditions Programme (ALC)
Umea
SE 901 87
Sweden

Website	http://www.umu.se/english
"ROR"	https://ror.org/05kb8h459

Funders

Funder type

Research council

Swedish Research Council (Sweden)
Government organisation / National government

Alternative name(s): Swedish Research Council, VR
Location: Sweden

Carl Wikstroms Foundation (Sweden)

No information available

Swedish Council for Working Life and Social Research (Sweden)
Private sector organisation / Other non-profit organizations

Alternative name(s): Swedish Council for Working Life and Social Research, FAS
Location: Sweden

Umea University (Sweden) - IB & CA Branholms Foundation

No information available

Erik & Anne-Marie Detlof Foundation (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan