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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Macular Degeneration and Aging Study

NCT02224963

Age-related Macular Degeneration

COMPLETED NA

A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)

NCT05780476

Caregiver Burden

UNKNOWN NA

Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia

NCT02397980

Alzheimer's Disease Dementia

UNKNOWN NA

Feasibility of Wearables in Dementia Care in Rural Taiwan

NCT07249918

Alzheimer's Dementia Neuropsychiatric Symptoms Related to Neurodegenerative Disease Wearable Devices +2 more

RECRUITING NA

Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.

NCT05658666

Dementia Nursing Home Resident Challenging Behavior

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Age Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Focus groups

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

Focus Groups

Intervention Type BEHAVIORAL

at least three focus groups lasting approximately one hour

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Focus Groups

at least three focus groups lasting approximately one hour

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Focus Group Discussion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)