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Reading Glass on Livelihoods and Quality of Life in Rural Bangladesh

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719196
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
VisionSpring
Information provided by (Responsible Party):
Farzana Sehrin, Brac

Tracking Information
First Submitted Date  ICMJE February 19, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date October 25, 2018
Actual Study Start Date  ICMJE March 30, 2017
Estimated Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
Income (Bangladeshi Taka) [ Time Frame: 7 to 8 months. ]
Each participant's income data will be captured before and after the intervention by structured questionnaire (e.g: how much taka you earned in last 30 days?). The data will then be calculated into per hour income before and after the intervention (8 months period) and will be compared between intervention and control group participants to see the difference.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
  • Secondary outcome 1: Difficulties in performing daily wise task: [ Time Frame: 7 to 8 months. ]
    • Likert scale (scale of 5) will be used to capture data on participants' Difficulties in performing daily wise tasks. Each question related to visual function is rated on a five-pointed scale consisting of (1) None; (2) Mild difficulty; (3) Moderate difficulty; (4) Severe difficulty; (5) Extreme difficulty.
  • Quality of vision: Likert scale [ Time Frame: 7 to 8 months. ]
    • Self-reported quality of vision as per responses of the respondents will be measured. Measurement will be based on a five point Likert scale as (1) Very Good; (2) Good; (3) Moderate; (4) Bad; (5) Very Bad.
  • Discomfort in functioning social activities [ Time Frame: 7 to 8 months. ]
    • Social functioning such as feel ashamed or discomfort due to eye problem in the society will be measured. Measurement will be based on a five point Likert scale consisting of (1) Never; (2) rarely; (3) Sometimes; (4) Often; (5) Very often.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reading Glass on Livelihoods and Quality of Life in Rural Bangladesh
Official Title  ICMJE Assessment of the Impact of Reading Glasses on Livelihoods and Quality of Life in the Context of Rural Bangladesh
Brief Summary

The issue of uncorrected Presbyopia is an emerging health and livelihoods problem in Bangladesh. Presbyopia is easily corrected with an appropriate pair of reading glasses. Non-governmental organizations and government agencies have been working in many emerging markets, including Bangladesh, to increase eyeglass coverage among low-income adults by introducing basic vision screening and the dispensing of reading glasses at the community level. While vision screening is typically considered a health intervention, the primary motivation of these organizations and government agencies is to correct blurry vision with the intention of improving adults' income earning potential.

VisionSpring and BRAC (previously know as Bangladesh Rural Advancement Committee. Now it is know as BRAC-no full form used) are two such NGOs who are partnering to implement a "Reading Glasses for Improved Livelihoods" program. VisionSpring is a social enterprise with a mission to increase access to affordable eye care and glasses in low-income settings. BRAC is an international development organization dedicated to alleviating poverty by empowering the poor.

VisionSpring and BRAC have initiated a Randomized Control Trial to assess the economic and social impact that reading glasses may have on individuals that earn less than $4 a day. The study hypothesizes that post-intervention, the adoption of reading glasses will increase productivity related to paid work and non-paid household activity, and will enhance the vision-related quality of life of adults with Presbyopia.

This experimental trial is designed to test the aforementioned hypotheses. In March 2017 a census survey was conducted in 59 villages of adults aged ≥35 and ≤65 years old in order to identify individuals with uncorrected presbyopia who would be eligible for enrollment in the study intervention. Following household visual acuity screenings, study participants were selected for enrollment. Randomization was conducted at the household level. Based on the inclusion criteria, a total of 1086 random households were surveyed at the baseline. Following completion of the baseline survey, in August 2017 the treatment group was given reading glasses free-of-cost. The endline survey will be conducted in May 2018, eight months from the baseline. Although some income-related outcomes may take more time to manifest, it is anticipated that the wearing of glasses precipitates changes in a relatively short time frame. The control group will receive reading glasses at the conclusion of the endline survey.

Detailed Description

BRAC (previously know as Bangladesh Rural Advancement Committee. Now it is know as BRAC-no full form used) has conducted a study on the Assessment of the Impact of Reading Glasses on Livelihoods and Quality of Life in the Context of Rural Bangladesh in 2017 with financial and technical assistance from VisionSpring. The goal is to assess the impact of reading glasses on economic return and social angles for people in rural areas in Bangladesh.

BRAC and VisionSpring have developed an experimental trial to test the effects of reading glasses. The study will utilize both pre and post-intervention data to identify the causal effects. A randomized control trial is considered to be the most rigorous method of determining whether a causal relationship exists between an intervention and outcome. This is a Randomized Control Trial (RCT) conducted at the household level.

First, investigators selected 59 villages in Bangladesh where the BRAC/VisionSpring distribution of reading glasses has not been present. A census survey was carried out in the 59 villages to identify those suffering from Presbyopia who were eligible for glasses.

Second, participants were recruited through a household Presbyopia screening of individuals over 35 years old and less than 65 years old. Participants with chronic eye diseases that require regular and intensive treatment were excluded from the study.

A structured questionnaire was used at the census survey where demographic information, income, and occupation were asked. Randomization was taken place after the census survey, and a study sample was selected based on the inclusion criteria of the study which are: (1) Over 35 years of age, (2) Presbyopia positive, (3) Have never used reading glass, (4) Selective occupation (tailor, barber, self-employed artisan etc), (5) Willing to provide contact information and give informed consent.

The study proposal defines two rounds of data collection to be conducted; baseline data collection was completed in August 2017 and follow-up data will be conducted in March 2018. A quantitative questionnaire was distributed at the baseline survey in order to understand the livelihoods and quality of life before the intervention began. Skilled interviewers were recruited for this study, and a three-day intensive training was held to reinforce the goals of the study. The training module was developed in Bangla to guide the interviewers in the field. Questions related to socio-demographic characteristics, economic status of the household (e.g. monthly income), the productivity of the respondent and quality were collected during baseline, and the same questionnaire will be used in the baseline survey.

A multi-stage simple random sampling technique has been used in this study. The sample size of the study is pre-determined through a power calculation, the inclusion criteria of being a Presbyopic patient. Power calculations are prescribed in randomized control trials to provide useful information on the likelihood of being able to reject the null hypothesis of zero effect. By using existing information on pre-intervention outcomes, investigators are able to calculate the Minimum Detectable Effect Size (MDES) for a given study. The Power calculations indicated that investigators would need a total sample size of 900 individuals to detect an effect size of 0.186 with power = 0.80. In essence, through this study design, investigators should be able to detect causal changes from 18.6% and up in the key variable of interest. Investigators selected 900 households (450 participate in the program, 450 individuals as control)to detect relatively small but meaningful effect size with sufficient accuracy. Assuming 15% attrition rate, the total sample would be 1036 households. At the baseline, a total of 1086 random households have been surveyed (T=555; C=531).

As the study is randomized at the individual level, there is a possibility to have the spillover effect. To minimize the spillover effect, one participant was selected from each household. There is a risk that members of the control group may see the benefits experienced by others in their community and buy a pair of reading glasses during the study. In an attempt to mitigate this risk, members of the control group were promised free glasses at the end of the study.

Investigators will use a difference-in-difference analysis to estimate the impact of the reading glasses study based on monthly income, unemployment rate, the productivity of both paid and unpaid work, the rate of mistakes or accidents that occur at work, and ability to read, and ability to do detailed oriented work.

To measure the impact of reading glasses on income, investigators will rely on respondent's economic indicators (monthly income, unemployment condition due to near vision problem, expenditure on food and household goods, etc.).

With respect to measuring productivity outcomes, investigators will rely on indicators to calculate outputs per time period for both paid and unpaid work (number of hours needed to complete a task by occupation, how many hours worked, output production per time period.).

To measure the quality of life, investigators will look at respondents perceptions of their facility with caregiving, household work, ability to (for those who are literate), mobile phone use, personal hygiene, and dependence.

Using this data, the investigators plan to estimate the impact of reading glasses on both livelihoods and quality of life.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Presbyopia
Intervention  ICMJE Other: Reading glass
Participants from the experimental group have received reading glasses free of cost. Investigators hypothesize that a simple pair of eyeglasses could improve the lives of these people by enabling continued participation in the workforce, restoring productivity levels in both paid and unpaid work, and enhancing the ability to perform everyday tasks. Investigators also hypothesize that reading glasses will improve quality of life.
Study Arms  ICMJE
  • Experimental: Reading glass provided

    Randomization took place after conducting the census survey. Participants were selected based on the inclusion criteria.

    555 random households were surveyed at the baseline. These households have been given reading glasses free of cost.

    Intervention: Other: Reading glass
  • No Intervention: Non-reading glass
    A total of 1086 households were surveyed at the baseline survey. Among them, 555 households have been provided reading glasses. The 531 remaining households were not given reading glasses during the baseline survey. The endline survey will be conducted in May 2018. Upon completing the endline survey, the non-reading glasses group will be provided reading glasses.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2018)
1086
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2018
Estimated Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Over 35 years of age
  • Presbyopia positive
  • Has never used reading glass or any other eyeglasses
  • Selective occupations associated with the need for clear vision at near distances (tailor, barber, self-employed artisan, housewife, etc)
  • Willing to provide contact information and give informed consent

Exclusion Criteria:

  • Less than 35 years of age
  • Presbyopia negative
  • Serious medical/mental and or eye condition, and
  • Meets criteria but does not wish to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kamrun Naher +8801761303087 ext 3727 kamrunnaherkemy@gmail.com
Contact: Altamas Pasha +8801716494887 ext 3727 altamas.p@brac.net
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03719196
Other Study ID Numbers  ICMJE RED_101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Farzana Sehrin, Brac
Study Sponsor  ICMJE Brac
Collaborators  ICMJE VisionSpring
Investigators  ICMJE
Study Director: Narayan Chandra Das Brac
PRS Account Brac
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP