DeafnessEarly Phase 1DSLWNCT01109576
Workshops for Veterans With Vision and Hearing Loss
A Early Phase 1 study testing DSL Workshop in people with Deafness and Blindness, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial. Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- DSL Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Aug 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Veteran;
- Vision loss > 20/70 better eye;
- Hearing loss > 40 decibels better ear;
- Cognition Within Normal Limits (WNL);
- No behavioral flag or psychiatric diagnosis;
- Documented psychosocial restrictions secondary to vision and hearing loss
Who cannot join
- Vision and/or hearing can be corrected by surgical or pharmacological treatment;
- Requires use of sign language interpreter
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97201
About this study
Official title: Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss
This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.
Read the detailed description
This pilot study will enrolled 13 Veterans with Dual Sensory Loss (DSL), age 65 to over 89. The project headquarters in the Portland Oregon Veterans Affairs Medical Center will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators enrolled the 13 Veterans. Staff turnover reduced time available for enrollment and data collection. We therefore eliminated the original comparison group design and this study had only one experimental intervention arm and no control intervention or other arm. Veterans were chronologically enrolled who responded to recruitment letters and who passed telephone and onsite screening. The intervention consisted of six weekly two hour workshops providing information, skills training and exercises about self-managing DSL effects on daily life. Preliminary effectiveness data was collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach. This study data tracked pre and post intervention within subject changes.
- Being tested
- DSL Workshop
- Keywords
- deafness-blindness, pilot study, self management education, dual sensory loss, rehabilitation, peer support groups, age related
- Medical subject headings
- Deafness, Blindness, Deaf-Blind Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSL WorkshopBehavioural
Also called Dual Sensory Loss Self Management Groups
A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.
| Study group | Role | What they receive |
|---|---|---|
| DSL workshop participants | Experimental | Three to five Veterans with DSL. Receives: Behavioral: DSL Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Profile of Mood States Total Score.
The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.
Measured: Change in Profile of Mood States Score from Baseline to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeafnessStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Atlanta VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Mitchel Turbin, PhD, Principal investigator, Veterans Health Administration (VHA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109576
- Sponsor's protocol ID
- C7460-P
- Acronym
- DSLW
- Status last verified
- Aug 2015
- First submitted
- 19 Apr 2010
- Last updated
- 29 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss
- ClinicalTrials.gov ID
- NCT01109576
- Acronym / sponsor ID
- DSLW / C7460-P
- Keywords
- deafness-blindness, pilot study, self management education, dual sensory loss, rehabilitation, peer support groups, age related
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Atlanta VA Medical Center
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Posted 29 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.
Detailed description
This pilot study will enrolled 13 Veterans with Dual Sensory Loss (DSL), age 65 to over 89. The project headquarters in the Portland Oregon Veterans Affairs Medical Center will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators enrolled the 13 Veterans. Staff turnover reduced time available for enrollment and data collection. We therefore eliminated the original comparison group design and this study had only one experimental intervention arm and no control intervention or other arm. Veterans were chronologically enrolled who responded to recruitment letters and who passed telephone and onsite screening. The intervention consisted of six weekly two hour workshops providing information, skills training and exercises about self-managing DSL effects on daily life. Preliminary effectiveness data was collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach. This study data tracked pre and post intervention within subject changes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSL workshop participants | Experimental | Behavioral: DSL WorkshopThree to five Veterans with DSL. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veteran;
- Vision loss > 20/70 better eye;
- Hearing loss > 40 decibels better ear;
- Cognition Within Normal Limits (WNL);
- No behavioral flag or psychiatric diagnosis;
Key exclusion criteria (2 listed)
- Vision and/or hearing can be corrected by surgical or pharmacological treatment;
- Requires use of sign language interpreter
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 |
|---|---|---|
| DSL WorkshopAlso: Dual Sensory Loss Self Management GroupsA series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers. | Behavioural | DSL workshop participants |
Primary outcome
Change in Profile of Mood States Total Score.
Time frame: Change in Profile of Mood States Score from Baseline to 8 Weeks
The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mitchel Turbin, PhD principal investigator
Veterans Health Administration (VHA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DSL Workshop in people with Deafness and Blindness, run by US Department of Veterans Affairs at 2 sites in United States.
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 6 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Profile of Mood States Total Score. (time frame: Change in Profile of Mood States Score from Baseline to 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2015.