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Self-management for Dual Sensory Impaired

Primary Purpose

Hearing Loss, Low Vision

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Self management program
self management program
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Loss focused on measuring Aged, Homes for the aged, Self management, Personal autonomy, Disease management, Self efficacy, Participation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation Riethorst Stromenland
  • Foundation Zorggroep Noord-Limburg
  • Maasduinen Foundation
  • Zorgbalans Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self management

Arm Description

Outcomes

Primary Outcome Measures

Participation in social, leisure and communicative activities.
2 outcome measures will be used: Activity Card Sort (Baum & Edwards 2001): change from baseline in leisure activities and social contacts at 6 months Hearing Handicap Questionnaire (Gatehouse & Noble 2004): change from baseline in communicative contacts at 6 months

Secondary Outcome Measures

work satisfaction professional caregivers
Depressive feelings
Autonomy.
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

Full Information

First Posted
September 13, 2010
Last Updated
November 21, 2014
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01217502
Brief Title
Self-management for Dual Sensory Impaired
Official Title
Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Low Vision
Keywords
Aged, Homes for the aged, Self management, Personal autonomy, Disease management, Self efficacy, Participation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self management
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Self management program
Other Intervention Name(s)
Empowerment
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
self management program
Other Intervention Name(s)
self efficacy
Intervention Description
Learning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of the dual sensory impairment
Primary Outcome Measure Information:
Title
Participation in social, leisure and communicative activities.
Description
2 outcome measures will be used: Activity Card Sort (Baum & Edwards 2001): change from baseline in leisure activities and social contacts at 6 months Hearing Handicap Questionnaire (Gatehouse & Noble 2004): change from baseline in communicative contacts at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
work satisfaction professional caregivers
Time Frame
6 months
Title
Depressive feelings
Time Frame
6 months
Title
Autonomy.
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Vernooij-Dassen, Prof. dr.
Organizational Affiliation
Radboud University Nijmegen Medical Centre, The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
Foundation Riethorst Stromenland
City
Geertruidenberg
State/Province
Gelderland
ZIP/Postal Code
4931HV
Country
Netherlands
Facility Name
Foundation Zorggroep Noord-Limburg
City
Herkenbosch
State/Province
Limburg
ZIP/Postal Code
6075HE
Country
Netherlands
Facility Name
Maasduinen Foundation
City
Kaatsheuvel
State/Province
Noord-Brabant
ZIP/Postal Code
5171DA
Country
Netherlands
Facility Name
Zorgbalans Foundation
City
Haarlem
State/Province
Noord-Holland
ZIP/Postal Code
2034MC
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29371264
Citation
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.
Results Reference
derived
PubMed Identifier
27856482
Citation
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.
Results Reference
derived
PubMed Identifier
24099315
Citation
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.
Results Reference
derived

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Self-management for Dual Sensory Impaired

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