DisabilityNCT00278096
Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly
A study testing occupational therapy in people with Disability and Occupational Therapy, run by Leiden University Medical Center.
Trial summary
In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly. Read more about this study
- Who is it for?
- Ages 85 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Disability, Occupational Therapy
- What is being tested?
- occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to May 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 85 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 85 years
- living independently
- MMSE score > 18 points
Who cannot join
- none
About this study
In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly.
Read the detailed description
Community-dwelling elderly, and particularly the oldest old, are generally viewed as highly susceptible to the 'inverse care law'. That is, those in greatest need for preventive assessment and surveillance have the highest potential benefit but are most likely to be missed. Hence, active case-finding and close follow-up might be an important strategy for maintaining the health, independence, and well-being of very elderly people who are at a particularly high risk.
In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly. Subjects in the intervention group will be visited by an occupational therapist who provides training and education about assistive devices that are already present and will give recommendations and information about procedures, possibilities, and costs of assistive devices and community-based services. Control subjects will not be visited by an occupational therapist.
The primary outcome measure of the trial will be the score on the Groningen Activity Restriction Scale (GARS). Secondary outcome measures will be well-being and feelings of loneliness.
- Conditions
- Disability, Occupational Therapy
- Being tested
- occupational therapy
- Keywords
- disability, occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Groningen Activity Restriction Scale (GARS)
Secondary outcomes (1)
Well-being and feelings of loneliness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startMar 2000
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisabilityStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Investigators
- Anton JM de Craen, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278096
- Sponsor's protocol ID
- LUMC P 92/99
- Other IDs
- NWO014-91-006
- Status last verified
- Jan 2006
- First submitted
- 13 Jan 2006
- Last updated
- 18 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly
- ClinicalTrials.gov ID
- NCT00278096
- Acronym / sponsor ID
- LUMC P 92/99
- Conditions
- Disability, Occupational Therapy
- Keywords
- disability, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- Mar 2000
- Study completion
- May 2004
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly.
Detailed description
Community-dwelling elderly, and particularly the oldest old, are generally viewed as highly susceptible to the 'inverse care law'. That is, those in greatest need for preventive assessment and surveillance have the highest potential benefit but are most likely to be missed. Hence, active case-finding and close follow-up might be an important strategy for maintaining the health, independence, and well-being of very elderly people who are at a particularly high risk.
In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly. Subjects in the intervention group will be visited by an occupational therapist who provides training and education about assistive devices that are already present and will give recommendations and information about procedures, possibilities, and costs of assistive devices and community-based services. Control subjects will not be visited by an occupational therapist.
The primary outcome measure of the trial will be the score on the Groningen Activity Restriction Scale (GARS). Secondary outcome measures will be well-being and feelings of loneliness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 85 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age 85 years
- living independently
- MMSE score > 18 points
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occupational therapy | Behavioural | – |
Primary outcome
Score on the Groningen Activity Restriction Scale (GARS)
1 secondary outcome
Well-being and feelings of loneliness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton JM de Craen, PhD principal investigator
Leiden University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapy in people with Disability and Occupational Therapy, run by Leiden University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Groningen Activity Restriction Scale (GARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2006.