Effect of occupational therapy in elderly people living at home

ISRCTN	ISRCTN93873801
DOI	https://doi.org/10.1186/ISRCTN93873801
Secondary identifying numbers	N/A

Submission date: 21/02/2013
Registration date: 24/05/2013
Last edited: 24/01/2019

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Tove Lise Nielsen
Scientific

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

Study information

Study design	Single blind randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of a home-based occupational therapy rehabilitation program A randomized controlled trial
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2012
Completion date	31/03/2014

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/09/2012
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

Denmark

Study participating centre

VIA University College

Aarhus N
8200
Denmark

Sponsor information

VIA University College (Denmark)
University/education

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

Website	http://www.viauc.dk
"ROR"	https://ror.org/04ctbxy49

Funders

Funder type

Charity

The municipality of Randers (Denmark)

No information available

The Danish Association of Occupational Therapists (Denmark)

No information available

TrygFoundation (Demark)

No information available

VIA University College (Denmark) project no. 40833

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2019	24/01/2019	Yes	No

Editorial Notes

24/01/2019: Publication reference added