Living Successfully With Chronic Eye Diseases (ADAPT-LAH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Singapore Eye Research Institute
Sponsor:
Collaborators:
Ministry of Health, Singapore
University of Melbourne
Singapore National Eye Centre
Curtin University of Technology
Information provided by (Responsible Party):
Peggy Pei-Chia Chiang, Singapore Eye Research Institute
ClinicalTrials.gov Identifier:
NCT01879501
First received: April 10, 2013
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Chronic Diseases
Low Vision
Diabetic Retinopathy
Glaucoma
Age-related Macular Degeneration
Behavioral: Low Vision Self-Management Program

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

Resource links provided by NLM:


Further study details as provided by Singapore Eye Research Institute:

Primary Outcome Measures:
  • Vision-related quality of life [ Time Frame: up to 12 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879501

Contacts
Contact: Peggy Chiang, PhD +6598548096 peggy.chiang.p.c@seri.com.sg
Contact: Chye Fong Peck +6593382666 peck.chye.fong@seri.com.sg

Locations
Singapore
Singapore National Eye Centre Recruiting
Singapore, Singapore, 168751
Contact: Priscilla Lim    +6597479490    Priscilla.Lim.S.H@snec.com.sg   
Contact: Ching Siong Tey, BSc    +6592968690    tey.ching.siong@seri.com.sg   
Principal Investigator: Peggy Chiang, PhD         
Sub-Investigator: Ecosse Lamoureux, PhD         
Sub-Investigator: Vicki Drury, PhD         
Sub-Investigator: Tien Yin Wong, PhD         
Sponsors and Collaborators
Singapore Eye Research Institute
Ministry of Health, Singapore
University of Melbourne
Singapore National Eye Centre
Curtin University of Technology
Investigators
Principal Investigator: Peggy PC Chiang, PhD Singapore Eye Research Institute (SERI)
  More Information

No publications provided

Responsible Party: Peggy Pei-Chia Chiang, Doctor, Singapore Eye Research Institute
ClinicalTrials.gov Identifier: NCT01879501     History of Changes
Other Study ID Numbers: HSRG11MAY005
Study First Received: April 10, 2013
Last Updated: June 14, 2013
Health Authority: Singapore: Ministry of Health

Keywords provided by Singapore Eye Research Institute:
Low vision
Self management
Randomized controlled trial
Quality of life
Self efficacy
Effectiveness
Chronic eye diseases management

Additional relevant MeSH terms:
Vision Disorders
Macular Degeneration
Diabetic Retinopathy
Eye Diseases
Chronic Disease
Vision, Low
Retinal Degeneration
Retinal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014