Hearing LossNCT01217502
Self-management for Dual Sensory Impaired
A study testing Self management program in people with Hearing Loss and Low Vision, run by Radboud University Medical Center at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hearing Loss, Low Vision
- What is being tested?
- Self management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 4 sitesNetherlands
- Study dates
- Nov 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- congenital deaf persons
- a dual sensory loss before the age of 55
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Foundation Riethorst Stromenland
Geertruidenberg, Gelderland, 4931HV
Zorgbalans Foundation
Haarlem, North Holland, 2034MC
Foundation Zorggroep Noord-Limburg
Herkenbosch, Limburg, 6075HE
Maasduinen Foundation
Kaatsheuvel, North Brabant, 5171DA
About this study
Official title: 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.
- Conditions
- Hearing Loss, Low Vision
- Being tested
- Self management program
- Keywords
- Aged, Homes for the aged, Self management, Personal autonomy, Disease management, Self efficacy, Participation
- Medical subject headings
- Hearing Loss, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self management programBehavioural
Also called Empowerment
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 programBehavioural
Also called self efficacy
Learning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of the dual sensory impairment
| Study group | Role | What they receive |
|---|---|---|
| Self management | Experimental | Not described Receives: Behavioral: Self management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
work satisfaction professional caregivers
Measured: 6 months
Depressive feelings
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Vernooij-Dassen, Prof. dr., Study chair, Radboud University Nijmegen Medical Centre, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217502
- Sponsor's protocol ID
- Kalorama 1
- Status last verified
- Nov 2014
- First submitted
- 13 Sep 2010
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29371264Roets-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.
PubMed 27856482Roets-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.
PubMed 24099315
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?
- ClinicalTrials.gov ID
- NCT01217502
- Acronym / sponsor ID
- Kalorama 1
- Conditions
- Hearing Loss, Low Vision
- Keywords
- Aged, Homes for the aged, Self management, Personal autonomy, Disease management, Self efficacy, Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self management | Experimental | Behavioral: Self management program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- congenital deaf persons
- a dual sensory loss before the age of 55
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self management programAlso: EmpowermentProfessional caregivers will be trained in offering a self management program to aged persons with a dual sensory impairment. Duration of the program: 6 months | Behavioural | Self management |
| self management programAlso: self efficacyLearning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of the dual sensory impairment | Behavioural | Self management |
Primary outcome
Participation in social, leisure and communicative activities.
Time frame: 6 months
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
3 secondary outcomes
work satisfaction professional caregivers
Time frame: 6 months
Depressive feelings
Time frame: 6 months
Autonomy.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 29371264Roets-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.
- Derived from this study: PubMed 27856482Roets-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.
- Derived from this study: PubMed 24099315Roets-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Vernooij-Dassen, Prof. dr. study chair
Radboud University Nijmegen Medical Centre, The Netherlands
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self management program in people with Hearing Loss and Low Vision, run by Radboud University Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in social, leisure and communicative activities. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217502, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.