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Self-management for Dual Sensory Impaired

This study is currently recruiting participants.
Verified September 2010 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01217502
First received: September 13, 2010
Last updated: January 23, 2013
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention
Hearing Loss
Low Vision
 Behavioral: Self management program
Behavioral: self management program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Participation in social, leisure and communicative activities. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Depressive feelings [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Autonomy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 132
Study Start Date: November 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self management Behavioral: Self management program
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 Name: Empowerment
Behavioral: self management program
Learning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of the dual sensory impairment
Other Name: self efficacy

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217502

Contacts
Contact: G.M. Roets +31246847777 l.roets@kalorama.nl

Locations
Netherlands
Foundation Riethorst Stromenland Recruiting
Geertruidenberg, Gelderland, Netherlands, 4931HV
Contact: Lea Beks     0031162408120        
Foundation Zorggroep Noord-Limburg Recruiting
Herkenbosch, Limburg, Netherlands, 6075HE
Contact: Mirjam Driessen     0031475458220        
Maasduinen Foundation Recruiting
Kaatsheuvel, Noord-Brabant, Netherlands, 5171DA
Contact: Pieter Hermsen     003141654 14 00        
Zorgbalans Foundation Recruiting
Haarlem, Noord-Holland, Netherlands, 2034MC
Contact: Chris Noordhuis     0031238918 918        
Sponsors and Collaborators
Radboud University
Investigators
Study Chair: M. Vernooij-Dassen, Prof. dr. Radboud University Nijmegen Medical Centre, The Netherlands
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01217502     History of Changes
Other Study ID Numbers: Kalorama 1
Study First Received: September 13, 2010
Last Updated: January 23, 2013
Health Authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Aged
Homes for the aged
Self management
Personal autonomy
 Disease management
Self efficacy
Participation

Additional relevant MeSH terms:
Ear Diseases
Hearing Loss
Deafness
Vision, Low
Hearing Disorders
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vision Disorders
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013