Living Successfully With Chronic Eye Diseases

NCT ID: NCT01879501

Last Updated: 2013-06-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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

The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Finding the best evidenced-based management for chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient responsibility is the key to managing LV effectively.1 This means achieving optimum self management (SM).2 However, there are currently no LV SM programs in Singapore and none has been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to evaluate health interventions.

The aims of this study are to assess the effectiveness of the 'Living Successfully with Low Vision (LSLV)' program in improving quality of life (QoL) in 160 elderly people with LV attending the Singapore National Eye Centre (SNEC) LV clinic. Of these, 80 will be randomly allocated to receive the LSLV 4-week SM program while the remaining 80 will receive the usual care. Comparisons will be made to determine the efficacy of the LSLV program. QoL, self-efficacy, emotional well being, and vision-specific distress will be assessed 2 weeks after training, and at six months and 12 months post intervention.

This study will be the first evidenced-based RCT investigating the effectiveness of a novel vision-specific self-management strategy to improve QoL. It will also adopt a longitudinal design where the effectiveness of these interventions will be evaluated at 12 months-the first follow-up assessment of that duration at both national and international levels. Furthermore this will be the first study to characterize and profile the patients where the effect of the program did not demonstrate an improvement in both primary and secondary outcomes six months after its completion. The future clinical implications of this study include the potential to implement a successful model of LV rehabilitation in other tertiary centres around the country.

Detailed Description

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

The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Finding the best evidenced-based management for chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient responsibility is the key to managing LV effectively.1 This means achieving optimum self management (SM).2 However, there are currently no LV SM programs in Singapore and none has been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to evaluate health interventions.

Conditions

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

Chronic Diseases Low Vision Diabetic Retinopathy Glaucoma Age-related Macular Degeneration

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Low Vision Self-Management Program

Intervention: The program will work with participants to choose a specific and achievable goal they wish to achieve, involve participants in the learning process, provide information, explore experiences with low vision, and solutions to develop problem solving skills to enhance self efficacy. Participants will learn new techniques to cope with their activities of daily living. In addition to this, local guest experts in the field will be sourced and invited to provide training in aspects of low vision care.

Group Type EXPERIMENTAL

Low Vision Self-Management Program

Intervention Type BEHAVIORAL

The program has been describe above.

Usual Care

Usual care delivered at the Singapore National Eye Centre

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Low Vision Self-Management Program

The program has been describe above.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Age 45 years to 75 years
* Visual acuity ≤6/12 to ≤6/480 in the better eye after best correction OR
* Visual field of less than 10 degrees from the point of fixation, but with the potential to use vision for the planning and/or execution of a task
* Duration of low vision ≥ 2 years
* No cognitive impairment (as assessed with the 6-item cognitive impairment test)
* Have adequate hearing with/without aids to respond to normal conversation

Exclusion Criteria

* Not matching the above
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, Singapore

OTHER_GOV

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role collaborator

Singapore National Eye Centre

OTHER_GOV

Sponsor Role collaborator

Curtin University

OTHER

Sponsor Role collaborator

Singapore Eye Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peggy Pei-Chia Chiang

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peggy PC Chiang, PhD

Role: PRINCIPAL_INVESTIGATOR

Singapore Eye Research Institute (SERI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Singapore National Eye Centre

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peggy Chiang, PhD

Role: CONTACT

+6598548096

Chye Fong Peck

Role: CONTACT

+6593382666

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Priscilla Lim

Role: primary

+6597479490

Ching Siong Tey, BSc

Role: backup

+6592968690

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSRG11MAY005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.