Development of Core Outcomes for Age-related Macular Degeneration (AMD) Interventions- Caregivers' Perspective

NCT02567604 | Completed

• 1 other identifier: B15/31
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Focus groups

AMD patients' caregivers defined as people actively taking part in providing support for AMD patients (e.g. family members, unpaid friends, volunteers)

Behavioral: Focus Groups

Interventions

Focus Groups BEHAVIORAL

at least three focus groups lasting approximately one hour

Also known as: Focus Group Discussion

Focus groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

caregivers/ carers such as family members, unpaid friends or volunteers taking active part in providing help and support for AMD patients

You may qualify if:

• 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)

You may not qualify if:

• Non-English speaking participants
• Being a caregiver for less than 6 months
• Not having daily contact with AMD patients

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Centre for Experimental Medicine Queen's University Belfast

Belfast, Co.Antrim, BT12 6BA, United Kingdom

Location

Related Links

• rationale behind development of core outcome sets for different conditions

MeSH Terms

Conditions

Macular Degeneration

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

GB (1)