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
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