Age Related Macular Degeneration Clinical Trial
Official title:
Development of Core Outcomes for Age-related Macular Degeneration (AMD)
NCT number | NCT02567604 |
Other study ID # | B15/31 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | September 2018 |
Verified date | January 2020 |
Source | Queen's University, Belfast |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - Non-English speaking participants - Being a caregiver for less than 6 months - Not having daily contact with AMD patients |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Experimental Medicine Queen's University Belfast | Belfast | Co.Antrim |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | up to 60 minutes |
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