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

Sponsor
Queen's University, Belfast (Other)
Overall Status
Completed
CT.gov ID
NCT02567604
Collaborator
(none)
5
Enrollment
1
Location
35
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Focus Groups

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

Study Type:
Observational
Actual Enrollment :
5 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Development of Core Outcomes for Age-related Macular Degeneration (AMD)
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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
at least three focus groups lasting approximately one hour
Other Names:
  • Focus Group Discussion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of potential COS (core outcome set) elements for AMD randomised controlled trials as assessed by the focus group discussions. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Experimental Medicine Queen's University Belfast Belfast Co.Antrim United Kingdom BT12 6BA

    Sponsors and Collaborators

    • Queen's University, Belfast

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Professor Augusto Azuara-Blanco, Professor of Ophthalmology, Queen's University, Belfast
    ClinicalTrials.gov Identifier:
    NCT02567604
    Other Study ID Numbers:
    • B15/31
    First Posted:
    Oct 5, 2015
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Jan 1, 2020
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Jan 13, 2020