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Living Successfully With Chronic Eye Diseases (ADAPT-LAH)

Primary Purpose

Chronic Diseases, Low Vision, Diabetic Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Low Vision Self-Management Program
Sponsored by
Singapore Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Diseases focused on measuring Low vision, Self management, Randomized controlled trial, Quality of life, Self efficacy, Effectiveness, Chronic eye diseases management

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore National Eye CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low Vision Self-Management Program

Usual Care

Arm Description

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.

Usual care delivered at the Singapore National Eye Centre

Outcomes

Primary Outcome Measures

Vision-related quality of life

Secondary Outcome Measures

Perceived self-efficacy, emotional well being, and vision-specific distress

Full Information

First Posted
April 10, 2013
Last Updated
June 14, 2013
Sponsor
Singapore Eye Research Institute
Collaborators
Ministry of Health, Singapore, University of Melbourne, Singapore National Eye Centre, Curtin University
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1. Study Identification

Unique Protocol Identification Number
NCT01879501
Brief Title
Living Successfully With Chronic Eye Diseases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Eye Research Institute
Collaborators
Ministry of Health, Singapore, University of Melbourne, Singapore National Eye Centre, Curtin University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases, Low Vision, Diabetic Retinopathy, Glaucoma, Age-related Macular Degeneration
Keywords
Low vision, Self management, Randomized controlled trial, Quality of life, Self efficacy, Effectiveness, Chronic eye diseases management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Vision Self-Management Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care delivered at the Singapore National Eye Centre
Intervention Type
Behavioral
Intervention Name(s)
Low Vision Self-Management Program
Intervention Description
The program has been describe above.
Primary Outcome Measure Information:
Title
Vision-related quality of life
Time Frame
up to 12 months post intervention
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peggy Chiang, PhD
Phone
+6598548096
Email
peggy.chiang.p.c@seri.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Chye Fong Peck
Phone
+6593382666
Email
peck.chye.fong@seri.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy PC Chiang, PhD
Organizational Affiliation
Singapore Eye Research Institute (SERI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla Lim
Phone
+6597479490
Email
Priscilla.Lim.S.H@snec.com.sg
First Name & Middle Initial & Last Name & Degree
Ching Siong Tey, BSc
Phone
+6592968690
Email
tey.ching.siong@seri.com.sg
First Name & Middle Initial & Last Name & Degree
Peggy Chiang, PhD
First Name & Middle Initial & Last Name & Degree
Ecosse Lamoureux, PhD
First Name & Middle Initial & Last Name & Degree
Vicki Drury, PhD
First Name & Middle Initial & Last Name & Degree
Tien Yin Wong, PhD

12. IPD Sharing Statement

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Living Successfully With Chronic Eye Diseases

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