Condition category
Musculoskeletal Diseases
Date applied
16/08/2007
Date assigned
05/09/2007
Last edited
12/09/2008
Prospective/Retrospective
Prospectively 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 Ingvild Kjeken

ORCID ID

Contact details

Diakonhjemmet Hospital/NRRK
Oslo
0319
Norway
+47 22 45 48 45
ingvild.kjeken@nrrk.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ATHOA

Study hypothesis

Study hypothesis updated as of 08/04/2008:
Although use of assistive technology is a frequent self help strategy in persons with hand osteoarthritis, there is a lack of high quality studies that examine the effect of assistive devices in this group. The aim of this study is to evaluate the effect of provision of assistive technology and patient education compared to patient education alone.

Study hypothesis provided at time of registration:
Although provision of assistive technology is one of the most frequent non-pharmacological, non-surgical interventions for persons with inflammatory rheumatic diseases, there is a lack of high quality studies that examine the effect of this intervention. The aim of this study is to evaluate the effect of provision of assistive technology and patient education compared to patient education alone.

Ethics approval

Ethical Committee for Medical Research and the Norwegian Data Inspectorate. Date of approval: 05/03/2008 (ref: 182-07240b 1.2007.1941)

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

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

Condition

Hand osteoarthritis

Intervention

Please note that, as of 08/04/2008, the anticipated start date of this trial was updated from 01/09/2007 to 15/04/2008.

Participants will be randomly allocated to the following two groups:

Group 1: Provision of assistive technology and patient education
Group 2: Patient education only

Provision of assitive technology includes involving the participants in selecting appropriate device(s) and training in use of the device(s).

Patient education includes provision of information about diagnosis and prognosis, and teaching of energy conservation and alternative working methods.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary outcome measures amended as of 22/04/2008:
The following will be assessed at baseline and three months:
1. Activity and participation, measured with the Canadian Occupational Performance Measure (COPM)
2. Pain during performance of prioritised activities, measured on visual analogue scales

Primary outcome measures provided at time of registration:
The following will be measured at baseline, 6 and 12 months:
1. Activity and participation, measured with the Canadian Occupational Performance Measure (COPM)
2. Pain during performance of prioritised activities, measured on visual analogue scales

Secondary outcome measures

Secondary outcome measures amended as of 22/04/2008:
The following will be assessed at baseline and three months:
1. Hand function, measured with the pain, stiffness and function subscales of the Australian/Canadian hand osteoarthritis measure (AUSCAN)
2. Functional ability, measured with the Modified health Assessment Questionnaire (MHAQ)
3. Hand pain, general pain, fatigue and disease activity, measured on visual analogue scales
4. Cost-effectiveness, measured with the Quality of Life Questionnaire (EQ-5D) and patient reported use of medication and health care resources

Secondary outcome measures provided at time of registration:
The following will be measured at baseline and 6 and 12 months:
1. Fatigue, measured with the Fatigue Impact Scale (FIS)
2. Quality of life, measured with the Arthritis Impact Scale (AIMS2)
3. Pain, fatigue and disease activity, measured on visual analogue scales.
4. Functional ability, measured with the Modified Health Assessment Questionnaire (MHAQ).
5. Cost-effectiveness, measured with the Quality of Life Questionnaire (15D) and patient reported use of medications and health care resources

Overall trial start date

15/04/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria updated as of 08/04/2008:
1. Age between 18 and 80 years
2. Hand osteoarthritis according to the American College of Rheumatology (ACR) criteria
3. Ability to communicate in Norwegian

Inclusion criteria provided at time of registration:
1. Age between 18 and 75 years
2. Rheumatoid Arthritis (RA), Juvenile Ideopatic Arthritis (JIA) or Psoriatic Arthritis (PsA) according to the American College of Rheumatology (ACR) criteria
3. Ability to communicate in Norwegian

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Target number as of 08/04/2008: 70. Target number at time of registration: 100

Participant exclusion criteria

Exclusion criteria updated as of 08/04/2008:
1. Cognitive or mental impairment
2. Hand surgery within the last 6 months
3. Change in medication within the last month
4. Impaired hand function due to trauma or diseases other than hand osteoarthritis

Exclusion criteria provided at time of registration:
1. Surgery within the last 6 months
2. Cognitive impairment or mental disease
3. Change in medication within the last month
4. Need for assistive technology due to surgery or to be able to be discharged from hospital

Recruitment start date

15/04/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Norway

Trial participating centre

Diakonhjemmet Hospital/NRRK
Oslo
0319
Norway

Sponsor information

Organisation

Diakonhjemmet Hospital (Norway)

Sponsor details

Boks 23 Vinderen
Oslo
0319
Norway
+47 22 45 15 00
administrasjon@diakonsyk.no

Sponsor type

Hospital/treatment centre

Website

http://www.diakonsyk.no

Funders

Funder type

Hospital/treatment centre

Funder name

The National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo (Norway)

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