Low VisionNCT03028493
Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision
A study testing Original SAFE Intervention and Adapted SAFE Intervention in people with Low Vision and Fall, run by Sarah Blaylock at 1 site in United States.
Trial summary
This study serves to test a previously evaluated falls prevention intervention recommended by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is accessible to older adults with low… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Vision, Fall
- What is being tested?
- Original SAFE Intervention and Adapted SAFE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 15 Dec 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 and older;
- Visual impairment with some remaining reading ability.
Who cannot join
- Less than age 60;
- Complete blindness;
- Vertebral osteoporosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veteran Affairs
Birmingham, Alabama, 35205
About this study
This study serves to test a previously evaluated falls prevention intervention recommended by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is accessible to older adults with low vision receiving services from the Southeastern Blind Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE intervention that has been adapted to be accessible for individuals with low vision at SBRC.
Read the detailed description
This study serves to compare the comprehension and retention of individuals completing a version of the SAFE falls prevention intervention adapted for low vision versus individuals receiving the original intervention. One group of participants will complete the standard SAFE intervention format while another group will complete the same intervention with written materials adapted for those with vision loss. One intervention (either standard or adapted SAFE program) will be delivered at a time. The SAFE intervention is comprised of four, 90-minute group classes that address environmental, behavioral, and physical falls risk factors. Classes involve lecture and group discussions as well as review of low intensity exercises. The adapted content is presented in large print with high contrast and has been rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts provided feedback to strengthen the adapted intervention.
- Conditions
- Low Vision, Fall
- Being tested
- Original SAFE Intervention, Adapted SAFE Intervention
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Original SAFE InterventionBehavioural
A CDC recommended, evidence-based falls prevention intervention.
Adapted SAFE InterventionBehavioural
An adapted version of the SAFE intervention meant to target older adults with low vision.
| Study group | Role | What they receive |
|---|---|---|
| Adapted SAFE Intervention | Experimental | Adapted version of the SAFE Health Behavior and Exercise intervention. Receives: Behavioral: Adapted SAFE Intervention |
| Original SAFE Intervention | Active comparator | Original version of the SAFE intervention. Receives: Behavioral: Original SAFE Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge of falls prevention
10 multiple choice questions based on the SAFE intervention content
Measured: Pre and post (2 weeks after start of intervention delivery)
Secondary outcomes (5)
Short Physical Performance Battery
Measures of balance, gait, and sit to stand
Measured: Pre
PROMIS Depression Scale
Measures depression
Measured: Pre
PROMIS Participation Scale
Measures daily participation
Measured: Pre
PROMIS Global Health
Measures general health
Measured: Pre
UAB Life-Space Inventory
Measures places travelled within past month
Measured: Pre
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start18 Jan 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Blaylock
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor-investigator, Sarah Blaylock, University of Alabama at Birmingham
- Investigators
- Cynthia Brown, MD, MSPH, Principal investigator, Birmingham VA and UAB School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028493
- Sponsor's protocol ID
- 01633
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data serves to fulfill dissertation requirement and will not be shared with additional researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision
- ClinicalTrials.gov ID
- NCT03028493
- Acronym / sponsor ID
- 01633
- Conditions
- Low Vision, Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sarah BlaylockUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 23 Jan 2017 (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 serves to test a previously evaluated falls prevention intervention recommended by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is accessible to older adults with low vision receiving services from the Southeastern Blind Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE intervention that has been adapted to be accessible for individuals with low vision at SBRC.
Detailed description
This study serves to compare the comprehension and retention of individuals completing a version of the SAFE falls prevention intervention adapted for low vision versus individuals receiving the original intervention. One group of participants will complete the standard SAFE intervention format while another group will complete the same intervention with written materials adapted for those with vision loss. One intervention (either standard or adapted SAFE program) will be delivered at a time. The SAFE intervention is comprised of four, 90-minute group classes that address environmental, behavioral, and physical falls risk factors. Classes involve lecture and group discussions as well as review of low intensity exercises. The adapted content is presented in large print with high contrast and has been rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts provided feedback to strengthen the adapted intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted SAFE Intervention | Experimental | Behavioral: Adapted SAFE InterventionAdapted version of the SAFE Health Behavior and Exercise intervention. |
| Original SAFE Intervention | Active comparator | Behavioral: Original SAFE InterventionOriginal version of the SAFE intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 and older;
- Visual impairment with some remaining reading ability.
Key exclusion criteria (3 listed)
- Less than age 60;
- Complete blindness;
- Vertebral osteoporosis.
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 |
|---|---|---|
| Original SAFE InterventionA CDC recommended, evidence-based falls prevention intervention. | Behavioural | Original SAFE Intervention |
| Adapted SAFE InterventionAn adapted version of the SAFE intervention meant to target older adults with low vision. | Behavioural | Adapted SAFE Intervention |
Primary outcome
Change in knowledge of falls prevention
Time frame: Pre and post (2 weeks after start of intervention delivery)
10 multiple choice questions based on the SAFE intervention content
5 secondary outcomes
Short Physical Performance Battery
Time frame: Pre
PROMIS Depression Scale
Time frame: Pre
PROMIS Participation Scale
Time frame: Pre
PROMIS Global Health
Time frame: Pre
UAB Life-Space Inventory
Time frame: Pre
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 4 Jan 2018.
- Individual participant dataSharing planned: No. All data serves to fulfill dissertation requirement and will not be shared with additional researchers.
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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.
Cynthia Brown, MD, MSPH principal investigator
Birmingham VA and UAB School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Original SAFE Intervention and Adapted SAFE Intervention in people with Low Vision and Fall, run by Sarah Blaylock at 1 site 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 2 inclusion and 3 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Change in knowledge of falls prevention (time frame: Pre and post (2 weeks after start of intervention delivery)). 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 4 Jan 2018.