Age Related Macular DegenerationNCT02567604
Development of Core Outcomes for Age-related Macular Degeneration (AMD) Interventions- Caregivers' Perspective
An observational study of Age Related Macular Degeneration, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
This study will explore experience of AMD caregivers in order to develop a core outcome set (COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying to capture what research outcomes are important from their perspective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Focus Groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Sep 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: caregivers/ carers such as family members, unpaid friends or volunteers taking active part in providing help and support for AMD patients
Who may be able to join
- English speaking participants
- AMD patients' caregivers defined as people actively taking part in providing support for AMD patients
- Being a caregiver for at least 6 months
- Having daily contact with AMD patients (not necessarily living with patients)
Who cannot join
- Non-English speaking participants
- Being a caregiver for less than 6 months
- Not having daily contact with AMD patients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Experimental Medicine Queen's University Belfast
Belfast, Co.Antrim, BT12 6BA
About this study
Official title: Development of Core Outcomes for Age-related Macular Degeneration (AMD)
This study will explore experience of AMD caregivers in order to develop a core outcome set (COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying to capture what research outcomes are important from their perspective.
People 18 years of age and older who have been AMD caregivers for at least 6 months may be eligible for this study.
The aim is to conduct three focus groups lasting approximately one hour. The plan is to enrol 18-24 participants (6-8 participants per each of 3 focus groups).Two researchers will be involved in conducting the focus groups. A moderator will ensure fluid discussion, while the second investigator will be taking notes and audio-recording the discussion.
Read the detailed description
Randomised controlled trials (RCTs) are widely employed interventional studies in medicine, yet many times their outcomes are presented inconsistently. The COMET Initiative (Core Outcome Measures for Effectiveness Trials) suggests that a solution for that issue would be preparation of a core outcome set (COS)a minimal group of outcome measures relevant to different group of stakeholders (e.g. clinicians, patients, carers) that would be implemented in each RCT in a particular area. The overall aim is to prepare a COS for age related-macular degeneration (AMD) RCTs. As first step to develop a COS for AMD, the investigators conducted a systematic review that confirmed variability in AMD trials' outcome selection. The current step encompasses involvement of different stakeholders' groups in focus groups: patients and caregivers (current project) such as family members and friends helping AMD patients with their everyday living. Knowledge of caregivers' perspective on living with, treatment and outcomes for AMD is a key consideration when building up a COS, because they may not only evaluate existing outcomes, but also their experience may be translate into new outcomes. In the current focus group study, caregivers will be invited for a one hour discussion. The investigators plan to arrange three focus groups with approximately 8 participants each. Two researchers will be present to help facilitate discussion. Participants will be asked about their experience related to their help brought to AMD patients, observations of living with and treatment of AMD as well as about AMD study outcomes and their importance.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Focus Groups
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupsBehavioural
Also called Focus Group Discussion
at least three focus groups lasting approximately one hour
| Study group | Role | What they receive |
|---|---|---|
| Focus groups | AMD patients' caregivers defined as people actively taking part in providing support for AMD patients (e.g. family members, unpaid friends, volunteers) Receives: Behavioral: Focus Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of potential COS (core outcome set) elements for AMD randomised controlled trials as assessed by the focus group discussions.
The expected list of COS (core outcome set) elements will plausibly include some of the visual function or anatomical measures as well as aspects of the quality of life. This study is a qualitative research study. No interventions will be given to the participants. No questionnaire or scale will be administered. The focus group discussions will aim to explore opinions of caregivers on outcomes used in AMD trials. Repeating themes of the discussions will be captured to form a potential COS for AMD trials.
Measured: up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2018
- Study completionSep 2018
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Augusto Azuara-Blanco, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567604
- Sponsor's protocol ID
- B15/31
- Status last verified
- Jan 2020
- First submitted
- 11 Sep 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Core Outcomes for Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT02567604
- Acronym / sponsor ID
- B15/31
- Conditions
- Age Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 5 Oct 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.
This study will explore experience of AMD caregivers in order to develop a core outcome set (COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying to capture what research outcomes are important from their perspective.
People 18 years of age and older who have been AMD caregivers for at least 6 months may be eligible for this study.
The aim is to conduct three focus groups lasting approximately one hour. The plan is to enrol 18-24 participants (6-8 participants per each of 3 focus groups).Two researchers will be involved in conducting the focus groups. A moderator will ensure fluid discussion, while the second investigator will be taking notes and audio-recording the discussion.
Detailed description
Randomised controlled trials (RCTs) are widely employed interventional studies in medicine, yet many times their outcomes are presented inconsistently. The COMET Initiative (Core Outcome Measures for Effectiveness Trials) suggests that a solution for that issue would be preparation of a core outcome set (COS)a minimal group of outcome measures relevant to different group of stakeholders (e.g. clinicians, patients, carers) that would be implemented in each RCT in a particular area. The overall aim is to prepare a COS for age related-macular degeneration (AMD) RCTs. As first step to develop a COS for AMD, the investigators conducted a systematic review that confirmed variability in AMD trials' outcome selection. The current step encompasses involvement of different stakeholders' groups in focus groups: patients and caregivers (current project) such as family members and friends helping AMD patients with their everyday living. Knowledge of caregivers' perspective on living with, treatment and outcomes for AMD is a key consideration when building up a COS, because they may not only evaluate existing outcomes, but also their experience may be translate into new outcomes. In the current focus group study, caregivers will be invited for a one hour discussion. The investigators plan to arrange three focus groups with approximately 8 participants each. Two researchers will be present to help facilitate discussion. Participants will be asked about their experience related to their help brought to AMD patients, observations of living with and treatment of AMD as well as about AMD study outcomes and their importance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus groups | – | Behavioral: Focus GroupsAMD patients' caregivers defined as people actively taking part in providing support for AMD patients (e.g. family members, unpaid friends, volunteers) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- caregivers/ carers such as family members, unpaid friends or volunteers taking active part in providing help and support for AMD patients
Key inclusion criteria (4 listed)
- English speaking participants
- AMD patients' caregivers defined as people actively taking part in providing support for AMD patients
- Being a caregiver for at least 6 months
- Having daily contact with AMD patients (not necessarily living with patients)
Key exclusion criteria (3 listed)
- Non-English speaking participants
- Being a caregiver for less than 6 months
- Not having daily contact with AMD patients
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 |
|---|---|---|
| Focus GroupsAlso: Focus Group Discussionat least three focus groups lasting approximately one hour | Behavioural | Focus groups |
Primary outcome
Number of potential COS (core outcome set) elements for AMD randomised controlled trials as assessed by the focus group discussions.
Time frame: up to 60 minutes
The expected list of COS (core outcome set) elements will plausibly include some of the visual function or anatomical measures as well as aspects of the quality of life. This study is a qualitative research study. No interventions will be given to the participants. No questionnaire or scale will be administered. The focus group discussions will aim to explore opinions of caregivers on outcomes used in AMD trials. Repeating themes of the discussions will be captured to form a potential COS for AMD trials.
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 Jan 2020.
- rationale behind development of core outcome sets for different conditionsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Queen's University, Belfast at 1 site in United Kingdom.
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 4 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 13 Jan 2020. 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 Kingdom. 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?
Number of potential COS (core outcome set) elements for AMD randomised controlled trials as assessed by the focus group discussions. (time frame: up to 60 minutes). 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 13 Jan 2020.