Age Related Macular DegenerationNCT03046485
Use of Self-management Group to Improve Quality of Life in Patients With Low Vision
A study testing Self management program 'Living with Vision Loss' in people with Age Related Macular Degeneration, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
120 Patients with visual acuity <6/12 will be randomized to receive either usual care or participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. Read more about this study
- Who is it for?
- Ages 55 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Self management program 'Living with Vision Loss'
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2016
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clients who have attended the MEEI Vision Rehabilitation for the first time within 12 months
- Visual acuity of <6/12 in the better eye with habitual correction
- Age 55+ years
- Living independently (not in a nursing home)
- English speaking
- No cognitive impairment
- Adequate hearing to respond to normal conversation
Who cannot join
- vestibular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision Rehabilitation Center
Boston, Massachusetts, 02114
About this study
Official title: A Randomized Controlled Trial to Assess if Attending an Interactive, Self-management Group, 'Living With Vision Loss', in Addition to Having Vision Rehabilitation in Our Clinic, Improves Patients' Quality of Life
120 Patients with visual acuity <6/12 will be randomized to receive either usual care or participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. We hypothesize that a structured self-management low-vision rehabilitation program provides a greater improvement in participation in daily activities, and improves quality of life in vision-impaired people compared to the provision of the usual low vision rehabilitation services. We also plan to document barriers that prevent patients with low vision (visual acuity <6/12) from participating in self-management course.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Self management program 'Living with Vision Loss'
- Keywords
- AMD, vision loss, self-management strategies, low-vision rehabilitation, IVI
- Medical subject headings
- Macular Degeneration, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self management program 'Living with Vision Loss'Behavioural
group met for 6 weeks, 2 hours per week, to discuss strategies for living with low vision
| Study group | Role | What they receive |
|---|---|---|
| Self management program | Experimental | Self management program 'Living with Vision Loss' 6 week course that met for 2 hours each week led by a trained leader. Receives: Behavioral: Self management program 'Living with Vision Loss' |
| Wait list control | No intervention | Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Vision Impairment Questionnaire (IVI)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startMay 2007
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Lou Jackson, Massachusetts Eye and Ear Infirmary
- Investigators
- Mary Lou Jackson, MD, Principal investigator, MEEI Vision REhabilitation Center Dir.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046485
- Sponsor's protocol ID
- 07-02-013
- Other IDs
- 07-02-013
- Status last verified
- Feb 2017
- First submitted
- 29 Oct 2010
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess if Attending an Interactive, Self-management Group, 'Living With Vision Loss', in Addition to Having Vision Rehabilitation in Our Clinic, Improves Patients' Quality of Life
- ClinicalTrials.gov ID
- NCT03046485
- Acronym / sponsor ID
- 07-02-013
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD, vision loss, self-management strategies, low-vision rehabilitation, IVI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Feb 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.
120 Patients with visual acuity <6/12 will be randomized to receive either usual care or participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. We hypothesize that a structured self-management low-vision rehabilitation program provides a greater improvement in participation in daily activities, and improves quality of life in vision-impaired people compared to the provision of the usual low vision rehabilitation services. We also plan to document barriers that prevent patients with low vision (visual acuity <6/12) from participating in self-management course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self management program | Experimental | Behavioral: Self management program 'Living with Vision Loss'Self management program 'Living with Vision Loss' 6 week course that met for 2 hours each week led by a trained leader. |
| Wait list control | No intervention | –Wait list control |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clients who have attended the MEEI Vision Rehabilitation for the first time within 12 months
- Visual acuity of <6/12 in the better eye with habitual correction
- Age 55+ years
- Living independently (not in a nursing home)
- English speaking
Key exclusion criteria (1 listed)
- vestibular disease
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 program 'Living with Vision Loss'group met for 6 weeks, 2 hours per week, to discuss strategies for living with low vision | Behavioural | Self management program |
Primary outcome
Impact of Vision Impairment Questionnaire (IVI)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Mary Lou Jackson, MD principal investigator
MEEI Vision REhabilitation Center Dir.
1 site 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 'Living with Vision Loss' in people with Age Related Macular Degeneration, run by Massachusetts Eye and Ear Infirmary 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 7 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Feb 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Impact of Vision Impairment Questionnaire (IVI) (time frame: 1 year). 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 8 Feb 2017.