Effect of Assistive Technology in patients with Hand OsteoArthritis: A randomised, controlled trial
| ISRCTN | ISRCTN61534918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61534918 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Diakonhjemmet Hospital/NRRK
Oslo
0319
Norway
| Phone | +47 22 45 48 45 |
|---|---|
| ingvild.kjeken@nrrk.no |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 15/04/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Target number as of 08/04/2008: 70. Target number at time of registration: 100 |
| 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
0319
Norway
Sponsor information
Diakonhjemmet Hospital (Norway)
Hospital/treatment centre
Hospital/treatment centre
Boks 23 Vinderen
Oslo
0319
Norway
| Phone | +47 22 45 15 00 |
|---|---|
| administrasjon@diakonsyk.no | |
| Website | http://www.diakonsyk.no |
"ROR" |
https://ror.org/02jvh3a15 |
Funders
Funder type
Hospital/treatment centre
The National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo (Norway)
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 |
