Living Successfully With Chronic Eye Diseases (ADAPT-LAH)

June 14, 2013 updated by: Peggy Pei-Chia Chiang, Singapore Eye Research Institute

Living Successfully With Chronic Eye Diseases: the 'Living Successfully With Low Vision' (LSLV) Program - a Randomized Controlled Trial of a Self-management Program for Low Vision

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 168751
        • Recruiting
        • Singapore National Eye Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peggy Chiang, PhD
        • Sub-Investigator:
          • Ecosse Lamoureux, PHD
        • Sub-Investigator:
          • Vicki Drury, PhD
        • Sub-Investigator:
          • Tien Yin Wong, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Low Vision Self-Management Program
The program has been describe above.
No Intervention: Usual Care
Usual care delivered at the Singapore National Eye Centre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vision-related quality of life
Time Frame: up to 12 months post intervention
up to 12 months post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Perceived self-efficacy, emotional well being, and vision-specific distress
Time Frame: baseline (before randomization to either usual care or intervention group); 2 weeks, 6 months and 12 months post intervention
baseline (before randomization to either usual care or intervention group); 2 weeks, 6 months and 12 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore Eye Research Institute

Collaborators

University of Melbourne
Curtin University
Singapore National Eye Centre
Ministry of Health, Singapore

Investigators

  • Principal Investigator: Peggy PC Chiang, PhD, Singapore Eye Research Institute (SERI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 14, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSRG11MAY005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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