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| Name | Class |
|---|---|
| Atlanta VA Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSL workshop participants | Experimental | Three to five Veterans with DSL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSL Workshop | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in Profile of Mood States Score from Baseline to 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel Turbin, PhD | Veterans Health Administration (VHA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur | Decatur | Georgia | 30033 | United States | ||
| VA Portland Health Care System, Portland, OR |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSL Workshop Participants | Three to five Veterans with DSL. DSL Workshop: 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. Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DSL Workshop Participants | Three to five Veterans with DSL. DSL Workshop: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in Profile of Mood States Score from Baseline to 8 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DSL Workshop Participants | Dual Sensory Loss (DSL) workshop participants. Three to five Veterans with DSL. DSL Workshop: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suicidal ideations | Psychiatric disorders | Non-systematic Assessment | One veteran participant presented with clinically significant depression and verbalized suicidal ideation to the study coordinator and subsequently was referred to the Suicide Prevention Coordinator at the Atlanta Veterans Affairs Medical Center. |
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The sample size was too small to draw any definitive conclusion from the data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchel Turbin, PhD | VHAPORHCS | 503-220-8262 | Bonnie.Becker@va.gov |
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| ID | Term |
|---|---|
| D003638 | Deafness |
| D001766 | Blindness |
| D054062 | Deaf-Blind Disorders |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
| Portland |
| Oregon |
| 97201 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Profiles of Mood States Total Score | The Profile of Mood States contains 65 self-reported items in 6 subscales (Tension, Depression, Anger, Vigor, Fatigue, and Confusion). Items are rated using a 5-point Likert Scale (scale: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). Total mood disturbance is calculated by subtracting the Vigor subscale score from the sum of the Tension, Depression, Anger, Fatigue, and Confusion subscale scores. Total scores can range from -32 to 200, with higher score indicating more mood disturbance. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| 1 |
| 13 |
| 0 |
| 13 |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D005128 | Eye Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |