Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295152
Status:
UNKNOWN
Last Update Posted:
2011-11-17
First Post:
2006-02-21
Brief Title:
Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers
Detailed Description:
1 Objective To determine the effects of community occupational therapy on the daily performance of older patients with mild to moderate dementia and the sense of competence of their primary caregivers
2 Methods
1 design a randomized controlled single-blind design is used with 3 measurement moments We measure at baseline before start of OT intervention after 6 weeks the effect measurementand after 3 months after baseline follow-up measurement
2 patients 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention with a power of 80 and alpha 0053 This power calculation is based on the outcomes of a pilot study Graff et al 2003
3 intervention 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an OT guidelineThe control group receives no OT intervention but usual care
4 main outcome measures are Assessment of Motor and Process Skills Interview in Deterioration of Daily Activities in Dementia IDDDand Sense of Competence Questionnaire SCQ
5 Analysis analyses of covariance on intention-to-treat basis Last Observation Carried Forward LCOFwill be used to determine the effects of community OT on the daily performance of older patients with dementia and the sense of competence of their primary caregivers Also secondary patientsand caregivers health outcomes will be analyzed by analyses of covariance on intention-to-treat basis
6 Cost-effectiveness the costs of this OT intervention will also be determined and a cost-effectiveness analysis will be carried out
3Results Results at baseline at 6 weeks and at 3 months follow-up on primary outcome measures and on patients and caregivers secondary health outcomes and also the cost effectiveness of this intervention will be analyzed and described in international publications
2 Methods
1 design a randomized controlled single-blind design is used with 3 measurement moments We measure at baseline before start of OT intervention after 6 weeks the effect measurementand after 3 months after baseline follow-up measurement
2 patients 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention with a power of 80 and alpha 0053 This power calculation is based on the outcomes of a pilot study Graff et al 2003
3 intervention 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an OT guidelineThe control group receives no OT intervention but usual care
4 main outcome measures are Assessment of Motor and Process Skills Interview in Deterioration of Daily Activities in Dementia IDDDand Sense of Competence Questionnaire SCQ
5 Analysis analyses of covariance on intention-to-treat basis Last Observation Carried Forward LCOFwill be used to determine the effects of community OT on the daily performance of older patients with dementia and the sense of competence of their primary caregivers Also secondary patientsand caregivers health outcomes will be analyzed by analyses of covariance on intention-to-treat basis
6 Cost-effectiveness the costs of this OT intervention will also be determined and a cost-effectiveness analysis will be carried out
3Results Results at baseline at 6 weeks and at 3 months follow-up on primary outcome measures and on patients and caregivers secondary health outcomes and also the cost effectiveness of this intervention will be analyzed and described in international publications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant V-1999-023 | None | None | None |