Condition category
Not Applicable
Date applied
21/02/2013
Date assigned
24/05/2013
Last edited
07/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
For the past decade, there has been an increase in the elderly population and the number is expected to rise. Therefore the number of elderly citizens requiring help from the municipality services will rise and this could lead to an increased economic burden on the municipalities in Denmark.
Occupational therapy focuses on the individual needs and desires and the environment in which the person lives. Participation in meaningful daily activities seems to have a positive effect on occupational performance, satisfaction, and quality of life, but there is a need for further investigation.
The aim is to investigate the effect of a 11 weeks’ home-based occupational therapy rehabilitation program for elderly citizens, compared to the usual municipal practice of home-based rehabilitation, in terms of changes in activity performance, satisfaction with activity performance, motor and process skills (body movement related skills) and quality of life.

Who can participate?
Home dwelling citizens of a medium-sized Danish municipality are included. They are of either sex, in the age group 60+, and newly referred or re-evaluated for home care. Excluded are citizens with well-defined severe diagnoses, drug abuse or severe pain, citizens with a rehabilitation plan from a hospital and citizens who cannot speak Danish without an interpreter.

What does the study involve?
The elderly citizens will be randomly allocated to the intervention group and the control group. The intervention group receives an intensive home-based occupational therapy rehabilitation program. They will be practicing daily activities of own choice; for 1 hour twice a week for 11 weeks. The control group receives the usual home-based rehabilitation of the municipality. Reassessments at follow-up are performed at 3 and 6 months after the start of the intervention.

What are the possible benefits and risks of participating?
We believe that the intensive occupational therapy program will help the citizens to perform their daily activities better and improve their quality of life. No risks are involved.

Where is the study run from?
The study is organized by VIA University College in collaboration with the Municipality of Randers. The occupational therapists involved in the study are employed by the Municipality of Randers.

When is the study starting and how long is it expected to run for?
The study started in September 2012 and will run till December 2014.

Who is funding the study?
The municipality of Randers, Denmark, VIA University College, The TRYG-foundation and the Danish Association of Occupational Therapists.

Who is the main contact?
Tove Lise Nielsen, OTR, Master of Health Science
ton@viauc.dk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Tove Lise Nielsen

ORCID ID

Contact details

VIA University College
Campus Aarhus N
Hedeager 2
room 43.32
Aarhus N
8200
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of a home-based occupational therapy rehabilitation program – A randomized controlled trial

Acronym

Study hypothesis

Elderly citizens randomised to receive occupational therapy will show improved self-reported occupational performance, improved satisfaction with own occupational performance, improved motor-and process skills and higher quality of life compared to elderly citizens randomised to receive treatment as usual offered by the municipality.

Ethics approval

The study is reported to The Local Ethical Committee, The Danish Data Protection Agency and the ethical principles in The Helsinki Declaration are followed.

The Danish Data Agency has approved the study in December 2012 (Jnr 2012-52-0049) http://www.datatilsynet.dk/english/.
The Ethical board of The Central Denmark Region has found that, according to Danish Legislation, the study shall not be further approved (De videnskabsetiske Komitéer for Region Midtjylland, Skottenborg 26, DK-8800 Viborg, Phone: + 45 7841 0183, E-mail: komite@rm.dk).

Study design

Single blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Occupational therapy for elderly citizens

Intervention

1. Intervention: Occupational therapy
2. Control: Treatment as usual

Citizens randomised to the intervention group will receive 60 minutes training by an occupational therapist twice a week for the total of 11 weeks. Two assessments are used to assess occupational performance and goal-setting: The Occupational Performance and Assessment of Motor and Process Skills (AMPS) by Ann Fisher and The Canadian Occupational Performance Measure (COPM) by The Canadian Association of Occupational Therapy. The identified needs and goals of the citizen are used to plan the occupational therapy intervention.

Masked follow-up assessments at 3 and 6 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Changes in self-reported occupational performance (COPM score) are calculated for the intervention and control groups and tested by Wilcoxon Rang Sum Test in order to statistically test if any difference between the two groups occur. Measured at 0 (baseline), 3, and 6 months.

Secondary outcome measures

1. Changes in satisfaction with own occupational performance (COPM score) are calculated for the intervention and control groups and tested by the Wilcoxon Rang Sum Test in order to statistically test if any any differences between the two groups occur.
2. Changes in motor and process skills (AMPS score) are calculated for the intervention and control groups and tested by a Wicoxon Rang Sum Test in order to test if any statistically significant difference occur between the two groups.
3. Changes in Quality of life (SF-36) are calculated for the intervention and control groups and between groups differences will be tested by T-test if data are normally distributed, or by a Wilcoxon Rang Sum Test if they are not normally distributed.

Measured at 0 (baseline), 3, and 6 months.

Overall trial start date

01/09/2012

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Citizens from 60 years of age, either sex
2. Living at home or in sheltered housing
3. Admissioned to either personal help and/or practical help and meal delivery from the municipality

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Citizens living in assisted living facilities
2. Having a serious mental illness, dementia, mentally handicapped
3. Suffering from cancer or severe pain

Recruitment start date

01/09/2012

Recruitment end date

31/03/2014

Locations

Countries of recruitment

Denmark

Trial participating centre

VIA University College
Aarhus N
8200
Denmark

Sponsor information

Organisation

VIA University College (Denmark)

Sponsor details

Faculty of Heath Sciences
Campus Aarhus N
Hedeager 2
Aarhus N
8200
Denmark

Sponsor type

University/education

Website

http://www.viauc.dk

Funders

Funder type

Charity

Funder name

The municipality of Randers (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Association of Occupational Therapists (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

TrygFoundation (Demark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

VIA University College (Denmark) project no. 40833

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