Condition category
Not Applicable
Date applied
29/10/2010
Date assigned
15/03/2011
Last edited
15/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ingeborg Nilsson

ORCID ID

Contact details

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

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 measures

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

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

http://www.umu.se/english

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

government non-federal

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes