NCT01217502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2010

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

3.5 years

First QC Date

September 13, 2010

Last Update Submit

November 21, 2014

Conditions

Hearing LossLow Vision

Keywords

AgedHomes for the agedSelf managementPersonal autonomyDisease managementSelf efficacyParticipation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • work satisfaction professional caregivers

    6 months

  • Depressive feelings

    6 months

  • Autonomy.

    6 months

Study Arms (1)

Self management

EXPERIMENTAL
Behavioral: Self management program

Interventions

self management programBEHAVIORAL

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

Also known as: Empowerment
Self management

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • congenital deaf persons
  • a dual sensory loss before the age of 55

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Foundation Riethorst Stromenland

Geertruidenberg, Gelderland, 4931HV, Netherlands

Location

Foundation Zorggroep Noord-Limburg

Herkenbosch, Limburg, 6075HE, Netherlands

Location

Maasduinen Foundation

Kaatsheuvel, North Brabant, 5171DA, Netherlands

Location

Zorgbalans Foundation

Haarlem, North Holland, 2034MC, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 29371264DERIVED

  • 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.

    PMID: 27856482DERIVED

  • 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.

    PMID: 24099315DERIVED

MeSH Terms

Conditions

Hearing LossVision, Low

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVision DisordersEye Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • M. Vernooij-Dassen, Prof. dr.

    Radboud University Nijmegen Medical Centre, The Netherlands

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2010

First Posted

October 8, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

NL(4)