- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217502
Self-management for Dual Sensory Impaired
November 21, 2014 updated by: Radboud University Medical Center
Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?
This study aims to determine the effectiveness of a self-management program for elderly with an acquired and concurrent hearing and visual impairment due to age-related disease processes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gelderland
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Geertruidenberg, Gelderland, Netherlands, 4931HV
- Foundation Riethorst Stromenland
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Limburg
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Herkenbosch, Limburg, Netherlands, 6075HE
- Foundation Zorggroep Noord-Limburg
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Noord-Brabant
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Kaatsheuvel, Noord-Brabant, Netherlands, 5171DA
- Maasduinen Foundation
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Noord-Holland
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Haarlem, Noord-Holland, Netherlands, 2034MC
- Zorgbalans Foundation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- clinical diagnosis of hearing loss and low vision
- at least one sensory loss acquired after the age of 55
- living in a home for the elderly
Exclusion Criteria:
- congenital deaf persons
- a dual sensory loss before the age of 55
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self management
|
Professional caregivers will be trained in offering a self management program to aged persons with a dual sensory impairment.
Duration of the program: 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participation in social, leisure and communicative activities.
Time Frame: 6 months
|
2 outcome measures will be used:
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
work satisfaction professional caregivers
Time Frame: 6 months
|
6 months
|
|
Depressive feelings
Time Frame: 6 months
|
6 months
|
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Autonomy.
Time Frame: 6 months
|
Outcome measure: 9-item Patient Autonomy Questionnaire (Vernooij-Dassen & Osse 2005): change from baseline in dependency, losing control, and limitation of activities at 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: M. Vernooij-Dassen, Prof. dr., Radboud University Nijmegen Medical Centre, The Netherlands
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roets-Merken LM, Zuidema SU, Vernooij-Dassen MJFJ, Teerenstra S, Hermsen PGJM, Kempen GIJM, Graff MJL. Effectiveness of a nurse-supported self-management programme for dual sensory impaired older adults in long-term care: a cluster randomised controlled trial. BMJ Open. 2018 Jan 24;8(1):e016674. doi: 10.1136/bmjopen-2017-016674.
- Roets-Merken LM, Vernooij-Dassen MJ, Zuidema SU, Dees MK, Hermsen PG, Kempen GI, Graff MJ. Evaluation of nurses' changing perceptions when trained to implement a self-management programme for dual sensory impaired older adults in long-term care: a qualitative study. BMJ Open. 2016 Nov 17;6(11):e013122. doi: 10.1136/bmjopen-2016-013122.
- Roets-Merken LM, Graff MJ, Zuidema SU, Hermsen PG, Teerenstra S, Kempen GI, Vernooij-Dassen MJ. Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial. Trials. 2013 Oct 7;14:321. doi: 10.1186/1745-6215-14-321.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
September 13, 2010
First Submitted That Met QC Criteria
October 7, 2010
First Posted (Estimate)
October 8, 2010
Study Record Updates
Last Update Posted (Estimate)
November 24, 2014
Last Update Submitted That Met QC Criteria
November 21, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kalorama 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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