GlaucomaNCT02347670
Comparison Study of Glaucoma Eye Care Follow-Up Adherence in a High Risk Population
A study testing Efficacy-patient navigator to improve follow-up adherence in people with Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The project aims to determine the effectiveness of a patient-centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educators, ophthalmic… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Efficacy-patient navigator to improve follow-up adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participated in the Wills Eye community-based comprehensive eye examination.
- Have a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using ICD-9 codes).
- Are recommended for follow-up care.
- Are willing and able to give informed consent and participate for 1 year.
- May have undergone laser therapy.
Who cannot join
- Are unwilling to go to any site for follow-up visits.
- Requested to follow-up only with their own ophthalmologist for their glaucoma eye-care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
The project aims to determine the effectiveness of a patient-centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educators, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits. The patient navigator will assist participants in community groups and a portion of the office-based participants with scheduling follow-up appointments
Read the detailed description
The Partridge Foundation has funded the Wills Eye Hospital Glaucoma Research Center for the project: Comparison Study of Glaucoma Eye Care Follow-up Adherence in a High-Risk Population to continue follow-up eye care for those who received a glaucoma diagnosis during the 2010 Center for Disease Control and Prevention funded cooperative agreement: Improving Access to Eye Care among High-Risk Persons for Glaucoma in Philadelphia Project. The project aims to determine the effectiveness of a patient -centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma.
There are approximately 700 potentially eligible persons from the 39 community sites, and of that the investigators hope to enroll 250 into 1 of four groups. Eligible participants have participated in the community-based comprehensive eye examination, have received a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using International Classification of Diseases (ICD)-9 codes), are recommended for follow-up care and have attended their Center for Disease Control and Prevention 6-month follow-up visit, are willing and able to give informed consent and participate for 1 year, any have undergone laser therapy. Excluded subjects are unwilling to attend randomized site for follow-up visits or prefers to continue follow-up eye care with their personal ophthalmologists.
Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educations, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits in community and office-based locations. A leased Wills Eye van will transport the intervention team and all necessary equipment to the site. The equipment will occupy a designated location at each site for 1 to 2 days per month, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. The same team will see participants who are randomized to the Wills Eye Glaucoma Research Center location.
Participants randomized to receiving help in patient navigation protocol at the community and office-based locations will receive more individualized care than others such as assistance with scheduling; a confirmation letter, text or email; a personal phone call the day before the appointment; and assistance with rescheduling appointments as needed and will consistently arrange transportation to appointments as needed, provide materials, and accompany study participants to their follow-up appointments at Wills Eye. Patient navigators, ocular technicians, and physicians will also communicate with family members regarding recommended follow-up visits, medication refills, and laser-therapy recommendations, as needed.
Participants randomized to usual care protocol at the office-based location will receive a phone number to call and schedule an appointment. Prior to the follow-up visit, participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. If participants do not show-up for their appointment that will be documented. Participants in the usual-care group will receive any necessary interpretation services, educational materials, and referrals to cataract surgery or other eye-care services, as needed. The intervention team will assure that participants with literacy issues can understand all information. This group is a realistic choice currently available for patients and thus will be used to compare with the patient navigator protocol.
- Conditions
- Glaucoma
- Being tested
- Efficacy-patient navigator to improve follow-up adherence, Office-Based Usual Care
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy-patient navigator to improve follow-up adherenceBehavioural
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.
Office-Based Usual CareBehavioural
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day.
This intervention group will receive a phone number to schedule an appointment. Participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure used at the Wills Eye Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Group 1M- Community Site | Active comparator | Participants randomized to Group 1-Main will attend follow-up visits at one of the four main community sites. A glaucoma specialist will perform the comprehensive eye examination and a ophthalmic technician will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire.
Intervention: Efficacy-patient navigator to improve follow-up adherence Receives: Behavioral: Efficacy-patient navigator to improve follow-up adherence |
| Group 2- Office-Based | Active comparator | Office-Based, Follow-Up Eye Care with Patient Navigation Protocol: Participants randomized to Group 2 will attend follow-up visits at the Wills Eye Hospital Glaucoma Research Center. A glaucoma specialist will perform the eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire.
Intervention: Efficacy-patient navigator to improve follow-up adherence Receives: Behavioral: Efficacy-patient navigator to improve follow-up adherence |
| Group 3- Office-Based | Active comparator | Group 3- follow-up eye care at the Wills Eye Hospital. There will be no charge or co-pay for these visits. Those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. These participants will receive a phone number to call and schedule their appointment and will receive a reminder phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. Group 3 represents a realistic choice currently available for patients and thus will be used to compare with usual care and will have 2-3 visits over the one-year period depending on diagnosis.
Intervention: Office-Based Usual Care Receives: Behavioral: Office-Based Usual Care |
| Group 1R- Community Site | Active comparator | Participants randomized to Group 1-Randomized will attend follow-up visits at one of the four main community sites, these participants were randomized from the 40 community sites to the closest community location. A glaucoma specialist will perform the comprehensive eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire.
Intervention: Efficacy-patient navigator to improve follow-up adherence Receives: Behavioral: Efficacy-patient navigator to improve follow-up adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Patient Navigator in a community setting or office based setting or usual care
Using data from randomized patients only, we will fit population average Poisson regression models using generalized estimating equations to estimate the rates of timely attendance by randomization assignment and assess the efficacy of the interventions while accounting for within-site clustering. The primary analysis will be adjusted for baseline individual characteristics believed to be associated with adherence to follow-up including age, glaucoma diagnosis, geriatric depression score, and overall vision-related quality of life.
Measured: Following 1 year
Secondary outcomes (2)
Differences between rates of follow-up adherence; Community Groups (1-Main v.s Group 1-Randomized).
This analysis will be primarily descriptive since although we expect follow-up to be higher in Group 1-Main (Main Community Group), we do not expect the difference to be large.
Measured: 1 Year
Effectiveness of the patient navigator intervention on long-term patterns of follow-up.
Additional secondary analysis will consider the effect of intervention on long-term patterns of follow-up. Since the pattern of expected visits differs by severity, we will classify subjects as long-term adherent if they attend all of their recommended follow-up visits and non-adherent otherwise. Analysis will use the same model as the primary outcome analysis.
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 posted27 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Partridge Foundation
- Responsible party
- Sponsor
- Investigators
- L. J. Katz, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347670
- Sponsor's protocol ID
- IRB#14-380
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2014
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript has been published.
Publications
Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016.
PubMed 27660423
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Glaucoma Eye Care Follow-Up Adherence in a High Risk Population
- ClinicalTrials.gov ID
- NCT02347670
- Acronym / sponsor ID
- IRB#14-380
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Partridge Foundation
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jan 2015 (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.
The project aims to determine the effectiveness of a patient-centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educators, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits. The patient navigator will assist participants in community groups and a portion of the office-based participants with scheduling follow-up appointments
Detailed description
The Partridge Foundation has funded the Wills Eye Hospital Glaucoma Research Center for the project: Comparison Study of Glaucoma Eye Care Follow-up Adherence in a High-Risk Population to continue follow-up eye care for those who received a glaucoma diagnosis during the 2010 Center for Disease Control and Prevention funded cooperative agreement: Improving Access to Eye Care among High-Risk Persons for Glaucoma in Philadelphia Project. The project aims to determine the effectiveness of a patient -centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma.
There are approximately 700 potentially eligible persons from the 39 community sites, and of that the investigators hope to enroll 250 into 1 of four groups. Eligible participants have participated in the community-based comprehensive eye examination, have received a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using International Classification of Diseases (ICD)-9 codes), are recommended for follow-up care and have attended their Center for Disease Control and Prevention 6-month follow-up visit, are willing and able to give informed consent and participate for 1 year, any have undergone laser therapy. Excluded subjects are unwilling to attend randomized site for follow-up visits or prefers to continue follow-up eye care with their personal ophthalmologists.
Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educations, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits in community and office-based locations. A leased Wills Eye van will transport the intervention team and all necessary equipment to the site. The equipment will occupy a designated location at each site for 1 to 2 days per month, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. The same team will see participants who are randomized to the Wills Eye Glaucoma Research Center location.
Participants randomized to receiving help in patient navigation protocol at the community and office-based locations will receive more individualized care than others such as assistance with scheduling; a confirmation letter, text or email; a personal phone call the day before the appointment; and assistance with rescheduling appointments as needed and will consistently arrange transportation to appointments as needed, provide materials, and accompany study participants to their follow-up appointments at Wills Eye. Patient navigators, ocular technicians, and physicians will also communicate with family members regarding recommended follow-up visits, medication refills, and laser-therapy recommendations, as needed.
Participants randomized to usual care protocol at the office-based location will receive a phone number to call and schedule an appointment. Prior to the follow-up visit, participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. If participants do not show-up for their appointment that will be documented. Participants in the usual-care group will receive any necessary interpretation services, educational materials, and referrals to cataract surgery or other eye-care services, as needed. The intervention team will assure that participants with literacy issues can understand all information. This group is a realistic choice currently available for patients and thus will be used to compare with the patient navigator protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1M- Community Site | Active comparator | Behavioral: Efficacy-patient navigator to improve follow-up adherenceParticipants randomized to Group 1-Main will attend follow-up visits at one of the four main community sites. A glaucoma specialist will perform the comprehensive eye examination and a ophthalmic technician will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. Intervention: Efficacy-patient navigator to improve follow-up adherence |
| Group 2- Office-Based | Active comparator | Behavioral: Efficacy-patient navigator to improve follow-up adherenceOffice-Based, Follow-Up Eye Care with Patient Navigation Protocol: Participants randomized to Group 2 will attend follow-up visits at the Wills Eye Hospital Glaucoma Research Center. A glaucoma specialist will perform the eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. Intervention: Efficacy-patient navigator to improve follow-up adherence |
| Group 3- Office-Based | Active comparator | Behavioral: Office-Based Usual CareGroup 3- follow-up eye care at the Wills Eye Hospital. There will be no charge or co-pay for these visits. Those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. These participants will receive a phone number to call and schedule their appointment and will receive a reminder phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. Group 3 represents a realistic choice currently available for patients and thus will be used to compare with usual care and will have 2-3 visits over the one-year period depending on diagnosis. Intervention: Office-Based Usual Care |
| Group 1R- Community Site | Active comparator | Behavioral: Efficacy-patient navigator to improve follow-up adherenceParticipants randomized to Group 1-Randomized will attend follow-up visits at one of the four main community sites, these participants were randomized from the 40 community sites to the closest community location. A glaucoma specialist will perform the comprehensive eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. Intervention: Efficacy-patient navigator to improve follow-up adherence |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participated in the Wills Eye community-based comprehensive eye examination.
- Have a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using ICD-9 codes).
- Are recommended for follow-up care.
- Are willing and able to give informed consent and participate for 1 year.
- May have undergone laser therapy.
Key exclusion criteria (2 listed)
- Are unwilling to go to any site for follow-up visits.
- Requested to follow-up only with their own ophthalmologist for their glaucoma eye-care.
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 |
|---|---|---|
| Efficacy-patient navigator to improve follow-up adherenceOver the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care. | Behavioural | Group 1M- Community Site, Group 1R- Community Site, Group 2- Office-Based |
| Office-Based Usual CareOver the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. This intervention group will receive a phone number to schedule an appointment. Participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure used at the Wills Eye Hospital. | Behavioural | Group 3- Office-Based |
Primary outcome
Efficacy of Patient Navigator in a community setting or office based setting or usual care
Time frame: Following 1 year
Using data from randomized patients only, we will fit population average Poisson regression models using generalized estimating equations to estimate the rates of timely attendance by randomization assignment and assess the efficacy of the interventions while accounting for within-site clustering. The primary analysis will be adjusted for baseline individual characteristics believed to be associated with adherence to follow-up including age, glaucoma diagnosis, geriatric depression score, and overall vision-related quality of life.
2 secondary outcomes
Differences between rates of follow-up adherence; Community Groups (1-Main v.s Group 1-Randomized).
Time frame: 1 Year
Effectiveness of the patient navigator intervention on long-term patterns of follow-up.
Time frame: 1 Year
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 13 Dec 2023.
- Background: PubMed 27660423Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016.
- Individual participant dataSharing planned: Yes. A manuscript has been published.
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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.
L. J. Katz, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy-patient navigator to improve follow-up adherence in people with Glaucoma, run by Wills Eye 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 5 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 13 Dec 2023. 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?
Efficacy of Patient Navigator in a community setting or office based setting or usual care (time frame: Following 1 year). 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 NCT02347670, which also lists 1 linked publication.
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 13 Dec 2023.