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Study Overview

Title:
Improving vision and health of elders in Nuwara Eliya district, Sri Lanka: An evaluation of the impact of community-based Elders’ Clubs on health, vision and well-being of elders
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-533c34a8b8734
Initial Registration Date:
04/02/2014
Last Update Date:
04/02/2014
Study Status:
Ongoing
Location(s):
Sri Lanka
Abstract:
Rapid ageing of populations in the Asian region is a significant development issue. Older people’s important contributions to their families and communities are often undermined by illness or disability, especially vision impairment. Social participation is associated with better health and well-being. But there have been no trials in low income settings of the impact of increased social participation on health and vision-related quality of life of elders. We are undertaking a cluster randomised trial to evaluate the impact of Elders’ Clubs, as part of the Better Vision, Healthy Ageing Program in Sri Lanka. The Program aims to improve the health, vision, and well-being of older people aged 60 years and above through establishing community Elders’ Clubs, and strengthening health preventive and care services. The trial is being conducted in the tea estates and rural villages in Nuwara Eliya district. Program partners include the Ministries of Health and Social Services, PALM Foundation, the Plantation Human Development Trust, Berendina and Sarvodaya. The findings will be significant for policy makers in Sri Lanka and in the broader Asian region.
Registration Citation:
Categories:
Health, Nutrition, and Population
Additional Keywords:
healthy ageing; vision impairment; social participation; Elders' Clubs, quality of life, noncommunicable diseases, health promotion
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Dr. Wendy Holmes
Affiliation:
Burnet Institute for Medical Research and Public Health, Melbourne, Australia
Name of Second PI:
2. Professor Stanley Luchters; 3. Dr. Gamini Jayakody
Affiliation:
Burnet Institute for Medical Research and Public Health, Melbourne, Australia; Central Provincial Health Department, Sri Lanka

Study Sponsor

Name:
The Fred Hollows Foundation
Study Sponsor Location:
Australia

Research Partner

Name of Partner Institution:
Provincial Health Department, Kandy, Sri Lanka; Ministry of Health Vision 2020 programme; PALM Foundation; PHDT; Sarvodaya; Berendina
Type of Organization:
Government agency (eg., statistics office, Ministry of Health)
Location:
Sri Lanka
Intervention

Intervention Overview

Intervention:
Establishment of, and support for, Elders’ Clubs at the community (village or tea estate) level. The intervention includes: - financial support to assist establishment of Elders' Club; monthly visits from program officers; community mapping; social activities such as dance, music, sports, oral history, and religious activities; health promotion activities, including peer education, picture card exercises, street drama; health and vision screening, and micro-finance activities. The median number of elders (aged 60 and above) in each Grama Niladhari (local government) Division is 247 (Range 28-530; inter quartile range: 126-374) in 1 – 7 communities. Clubs will be established in each community in 20 randomly selected GN Divisions and the leaders (one male; one female) of each of the Clubs will form a separate GN Division level Elders' Committee, in line with Sri Lankan government policy. The development of the Elders’ Clubs will vary depending on existing community structures and the different partners’ approaches, but will be undertaken in a coordinated way, guided by a manual. Another 20 randomly selected GN divisions will start Elders' Clubs after endline data collection.
Theory of Change:
Multiple Treatment Arms Evaluated?
No

Implementing Agency

Name of Organization:
A collaboration of PALM Foundation; Sarvodaya; Berendina; and Plantation Human Development Trust
Type of Organization:
NGO (local)/Community Based Organization/Other civil society organization

Program Funder

Name of Organization:
The Fred Hollows Foundation
Type of Organization:
NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
Yes
Start Date:
10/30/2013
End Date:
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (specify)
Other (not Listed) Method:
Qualitative methods (focus group discussions, key informant interviews, story telling)

Method Details

Details of Evaluation Approach:
This is a Cluster Randomized Controlled trial, nested within the Better Vision, Healthy Ageing Program. Forty clusters in the Program area consisting of GN Divisions (local administrative divisions) have been randomly selected proportionate-to-size. These clusters have been randomly assigned to have community-based Elders’ Clubs introduced and supported after the baseline data collection (Intervention arm) or later after the endline data collection (Control arm). Data will be collected to assess impact of Elders’ Club participation on health-related quality of life after 15 months. After that, Elders’ Clubs will also be introduced in the Control GN Divisions and supported for nine months until the end of the Program. In this way only 20 of the 93 GN divisions in the Program area will have the intervention delayed, and all the GN Divisions will have Elders’ Clubs introduced and supported within the Program period. The study population is older people aged 60 years and above and living in Walapane or Nuwara Eliya DS Divisions, Sri Lanka. A comprehensive, semi-structured, interviewer-administered questionnaire is used to collect the data.
Outcomes (Endpoints):
The primary endpoints related to the primary objectives are: a. Proportion of people aged 60 and above with a health-related quality of life (HR-QoL) score <50 using a validated, translated Sri Lankan Quality of Life scale (adapted from the WHO QOL BREF), after 15 months; b. Median score in the HR-QoL as assessed using the validated, translated Sri Lankan Quality of Life scale, after 15 months; c. Mean change in HR-QoL score as assessed using a the validated, translated Sri Lankan Quality of Life scale, after 15 months.
Unit of Analysis:
The main unit of analysis is the individual elders. We will also conduct some analyses at the level of the GN Division.
Hypotheses:
The following hypotheses will be tested: • Older people who participate in a community based Elders’ Club intervention will report an improvement in health-related quality of life compared with older people in a control area that has not yet received the intervention. • The Better Vision, Healthy Ageing Program will improve the vision-related quality of life of older people in the Program area and improve knowledge, attitudes and behaviours in relation to healthy and active ageing.
Unit of Intervention or Assignment:
GN Division (local government division)
Number of Clusters in Sample:
40
Number of Individuals in Sample:
1,200
Size of Treatment, Control, or Comparison Subsamples:
Intervention group: 600 older people 60 years or over in 20 clusters; Control group: 600 older people 60 years or over in 20 clusters.

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
Comprehensive interviewer-administered, semi-structured questionnaire, developed using predominantly previously validated scales. The questionnaire has been translated into both Tamil and Sinhala and pre-tested.
Data Already Collected?
No
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

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Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: