Self-management for Dual Sensory Impaired

Hearing Loss Clinical Trial

Official title:

Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217502
• Other study ID #: Kalorama 1
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: November 21, 2014
• Start date: November 2010
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hearing Loss
• Low Vision

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Foundation Riethorst Stromenland	Geertruidenberg	Gelderland
Netherlands	Zorgbalans Foundation	Haarlem	Noord-Holland
Netherlands	Foundation Zorggroep Noord-Limburg	Herkenbosch	Limburg
Netherlands	Maasduinen Foundation	Kaatsheuvel	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No
Secondary	work satisfaction professional caregivers		6 months	No
Secondary	Depressive feelings		6 months	No
Secondary	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	6 months	No