Living Successfully With Chronic Eye Diseases

Glaucoma Clinical Trial

— ADAPT-LAH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01879501
• Other study ID #: HSRG11MAY005
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2013
• Last updated: June 14, 2013
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2013
• Source: Singapore Eye Research Institute
• Contact: Peggy Chiang, PhD
• Phone: +6598548096
• Email: peggy.chiang.p.c[@]seri.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Chronic Disease
• Chronic Diseases
• Diabetic Retinopathy
• Eye Diseases
• Glaucoma
• Low Vision
• Macular Degeneration
• Vision, Low

Intervention

Behavioral:
• Low Vision Self-Management Program
The program has been describe above.

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (5)

Lead Sponsor	Collaborator
Singapore Eye Research Institute	Curtin University of Technology, Ministry of Health, Singapore, Singapore National Eye Centre, University of Melbourne

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision-related quality of life		up to 12 months post intervention	No
Secondary	Perceived self-efficacy, emotional well being, and vision-specific distress		baseline (before randomization to either usual care or intervention group); 2 weeks, 6 months and 12 months post intervention	No