Effect of Assistive Technology in patients with Hand OsteoArthritis: A randomised, controlled trial

ISRCTN	ISRCTN61534918
DOI	https://doi.org/10.1186/ISRCTN61534918
Protocol serial number	N/A
Sponsor	Diakonhjemmet Hospital (Norway)
Funder	The National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo (Norway)

Submission date: 16/08/2007
Registration date: 05/09/2007
Last edited: 12/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ingvild Kjeken
Scientific

Diakonhjemmet Hospital/NRRK
Oslo
0319
Norway

Phone	+47 22 45 48 45
Email	ingvild.kjeken@nrrk.no

Study information

Primary study design	Interventional
Study design	Randomised controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	ATHOA
Study objectives	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(s)	Ethical Committee for Medical Research and the Norwegian Data Inspectorate. Date of approval: 05/03/2008 (ref: 182-07240b 1.2007.1941)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	70
Key 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
Key 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
Date of first enrolment	15/04/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Norway

Study participating centre

Diakonhjemmet Hospital/NRRK

Oslo
0319
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes