Transforming Households With Refraction and Innovative Financial Technology
NCT ID: NCT05510687
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
571 participants
INTERVENTIONAL
2023-12-10
2026-01-31
Brief Summary
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The primary objective of the THRIFT trial is to assess whether the combined complementary intervention of providing free eyeglasses and basic digital financial services training in the use of mobile phones to recipients of government OAA and WA safety-net payments can lead to greater financial inclusion and improved quality of life.
THRIFT's primary outcome is the adoption and effective use of the DFS platform in receiving digital OAA and WA transfers using the mobile banking platform, as measured by the difference between the treatment and control groups.
The secondary outcomes analysed under the THRIFT trial will be:
Total mobile data consumption by the individual Whether use of the application was facilitated by a bKash agent or family member, or independently by the beneficiary Purchase of additional phones by study participant's household Purchase of additional phones by study participant Intra-household resource sharing by the beneficiary (as a percentage of total household consumption) Purchase of glasses other than those issued to the intervention group. Food security (measured using standard module developed by World Food Programme (WFP) Role of study participant in household decision making Subjective well-being of study participants Mobility of study participant Social connectedness of study participant Change in the average number of transactions per participant per quarter for 18-month period after the intervention, using transaction-level data from bKash Self-reported incidence of theft or fraudulent use of money from the index participant's account.
Detailed Description
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The proposed THRIFT trial is the first randomised trial to examine two important determinants of mobile banking among an elderly and financially vulnerable population in a developing country context: lack of awareness about the use of mobile banking, and uncorrected age-related decline in near vision, presbyopia.
The aim of the proposed RCT trial is to assess the impact of presbyopia correction and basic digital financial training (combined complementary intervention) on greater adoption and use of digital financial services (primary outcome) and other welfare impacts (secondary outcomes) for safety-net beneficiaries in an LMIC.
JPGSPH will gather the beneficiary list of the OAA and WA from the Department of Social Service, Government of Bangladesh.
Consent for Social screening and vision screening is obtained by Community Health workers (CHW) of MOMODa Foundation (MF) and consented participants are assigned the Unique participant Identifier (ID).
All the relevant documents are verified before proceeding to the social screening.
Social screening including numeracy, dexterity and cognitive test (NDC test) is done to confirm eligibility.
Eligible participant list is shared with VisionSpring (VS) team after obtaining consent for vision examinations.
VS CHWs and Programs officers conduct door-to door eye-screening for presbyopia diagnosis and eligible participant list is shared with MF for proceeding with baseline survey. Consent for baseline survey and trial is obtained by MF, followed by randomisation.
Treatment group gets the eyeglasses, mobile phone and basic training on the usage of the mobile phone and mobile banking application.
Control group gets mobile phone and basic instructions to use the mobile phone and prescription for glasses. Eyeglasses to the control group are provided at the end of the study.
VS team conducts 2 follow up visits per participant, one month and 6 months after receiving glasses with a one month additional window for each visit.
* to check the compliance to eyeglasses
* Collect any safety event information MOMODa Foundation team conducts 2 follow-up visits per participant at 3 and 6 months after providing the smartphones and training with a one month additional window for each visit.If it is not possible to meet during that window period, the survey will be completed by telephonic survey within the next 7 days after the allowed one-month window. MF
* collects any information on safety events
* checks the smartphones provided
* assesses the participants comfort to use the smartphone
* assesses whether smartphone is being used by the participant. MF conducts the endline survey 18 months after the distribution of the smartphones.
Study Setting:
The research will be conducted in Kurigram Sadar and Nageshwari, two sub-districts within the Kurigram district located in northern Bangladesh. These districts are in bKash catchment area for the Department of Social Services safety-net payments. Specifically, the study will take place in nine unions, seven in Kurigram Sadar and two in Nageshwari.
Recruitment: This will begin with the receipt of the list identifying OAA and WA beneficiaries living in Kurigram district from the Department of Social Service, Government of Bangladesh.
Before visiting the beneficiaries' households, the enumerators will make phone calls to schedule appointments.
MF will conduct a door-to-door social screening survey based on the eligibility criteria.
Numeracy, Dexterity and Cognition (NDC) Test: The study participants who will meet all inclusion criteria up to this point and attended the Social Screening Survey will undergo a basic numeracy and a functional literacy test. This is to assess if they can conduct basic operations using a phone, such as recognising numbers and using the smartphone screen number pad to enter numbers.
Before conducting the social screening survey and NDC test, beneficiaries will be requested to familiarise themselves with the numbers (English) from 0 to 9 prior to the scheduled household visit.
During this test, beneficiaries will be requested if they can see the numbers on app and based on the visual demand they will be given +1, +2 or +3 reading glasses starting with +1 for 48-50 age group, +2 for 51-60 age group, and +3 \>60 age.
Presbyopia diagnosis: Door-to-door eye screening examinations will be done to all the identified OAA and WA beneficiaries in the selected district who consent to be screened.
Baseline Survey: After undergoing social screening, NDC test, and vision screening, the individuals will be selected for the baseline survey.
RANDOMISATION AND PROCEDURES Participants will be randomly assigned to either the Intervention or Control Group using following procedure.
The randomization sequence will be generated by the study statistician at the L.V. Prasad Eye Institute Clinical Trials Unit (LVPEI CTU) using a pre-written code in Stata. Separate randomisation sequences will be prepared in advance for each of the 12 possible strata.
Allocation concealment mechanism The allocation sequence will be in a password protected location stored in designated folder for THRIFT by James P Grant School of public Health (JPGSPH) and will be accessed by the concealment implementers only.
The implementation team will receive a list of beneficiaries and their respective group allocation based on the baseline data collected. The group allocation for a participant will be revealed from the list and the participant is enrolled.
Blinding/Masking The trial will be investigator-masked, but CHWs, other fieldwork personnel and the participants will not be masked to Intervention Group assignment.
ANALYSIS Baseline demographic and clinical characteristics will be reported for all participants in the sample, excluding protocol deviations randomised in error where Informed Consent has not been obtained. Baseline characteristics will be summarised by their means and standard deviations, medians and interquartile ranges, or numbers and percentages as appropriate.
An intention to treat (ITT) approach will be used to analyse the trial outcomes. This will involve regressing the outcome of concern on the randomised intervention status, difference in differences (DID) for panel data will be used for analysis. The primary analysis will be stratified by (1) WA recipients vs OAA recipients (2) incoming vs. outgoing transactions, and (3) smartphone-based vs. non-smartphone-based transactions (e.. kiosk use). All analyses will be adjusted for age, gender, and previous phone use. Random imbalances may occur hence, both the crude and adjusted estimates will be presented, but the primary inference will be based on the adjusted analysis. Several studies with regional and rural samples have found vision problems to affect ageing populations in Bangladesh. Previously, there has been a gender gap in eye health in Bangladesh. In 2023, Orbis, the Fred Hollows Foundation and its partners started work to close this gap. Uncorrected vision problems have been found to negatively affect visual function, for example, smartphone and mobile phone usage among the elderly in multiple LMIC contexts.The rates of mobile banking usage, as measured in the primary outcomes, will be compared across groups of participants based on the basis of age, education, household income and other socioeconomic variables. Standard errors will be clustered at the individual level for this analysis. However, for high-frequency outcome variables (such as app-based financial transactions) data will be aggregated at the appropriate level (either monthly or weekly or quarterly), with errors clustered at the household level. Outcome variables that are binary in nature will be analysed using Linear Probability Model Method.
Participants will be described with respect to the following characteristics at trial entry:
Age, Sex, Education level, Uncorrected, presenting and corrected distance visual acuity in each eye separately and both eyes together, Ownership of glasses for the correction of distance vision and self-reported regularity of use Visual Function Questionnaire (VFQ-25), Rural residence, Attitudes towards vision correction, Access to local eye care services, history of uptake of eye care services.
Numbers (with percentages) for binary and categorical variables and means (and standard deviations), or medians (with lower and upper quartiles) for continuous variables will be presented; there will be no tests of statistical significance performed nor confidence intervals calculated for differences between groups on any baseline variables (for instance mid-way through trial from Interim Analysis).
Economic Evaluation An economic evaluation of the intervention will be conducted using cost-effectiveness analysis. Data will be collected on the incremental cost of providing eyeglasses to the Intervention Group to calculate the incremental cost per quality-of-life measure, which will help assess the cost-effectiveness of the intervention.
No planned interim analysis will be undertaken due to the short duration of the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Glasses to correct presbyopia and digital financial training
The intervention is the provision of glasses to correct presbyopia plus digital financial training to use bKash, a popular mobile banking application that is becoming the preferred mode of transferring payments to the bank accounts of OAA and WA beneficiaries in Bangladesh.
Glasses to correct presbyopia
Participants will receive eyeglasses to correct presbyopia, as per the power determined in the eye examination.
Control-No treatment
Mobile phone with preloaded bank transaction tracking app: Participants will be provided a basic mobile phone handset. The bank transaction tracking application that is being developed to measure the primary outcomes for this trial will be installed on these phones before giving them to the participants. A mobile data pack will also be remotely loaded on the mobile phone to facilitate internet access for mobile banking.
Eyeglasses: These participants will receive a free pair of eyeglasses at the conclusion of the study to correct refractive errors, unless they have obtained such glasses on their own during the study.
No interventions assigned to this group
Interventions
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Glasses to correct presbyopia
Participants will receive eyeglasses to correct presbyopia, as per the power determined in the eye examination.
Eligibility Criteria
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Inclusion Criteria
* 65-70 years old male OAA beneficiaries
* 62-70 years old female OAA beneficiaries
* 48-60 years old WA beneficiaries
2. Receiving digital OAA or WA payments from the Government of Bangladesh
3. Residence Lived in the bKash catchment area, Kurigram for 3 more
4. Presbyopia
* Binocular presenting near-vision N6.3 or worse, correctable to N5 or better
* Require a new pair of glasses
5. Mapped into bottom three asset quintiles according to the equity tool questionnaire
6. Numeracy, dexterity and cognitive ability Score 8 or above on NDC Screening test.
7. Individuals who do not use Mobile Financial Services (MFS) account by themselves
Exclusion Criteria
2. Presence of any cause of near or distance vision impairment that cannot be resolved with presbyopic glasses.
48 Years
70 Years
ALL
No
Sponsors
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L.V. Prasad Eye Institute
OTHER
VisionSpring
OTHER
MOMODa Foundation
UNKNOWN
Good Business Labs Foundation
UNKNOWN
Florida International University
OTHER
Clearly
OTHER
BRAC University
OTHER
Queen's University, Belfast
OTHER
Responsible Party
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Nathan Congdon
Principal Investigator
Principal Investigators
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Nathan G Congdon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Queen's University, Belfast
Atonu Rabbani, PhD
Role: PRINCIPAL_INVESTIGATOR
BRAC James P Grant School of Public Health
Abu S Shonchoy, PhD
Role: PRINCIPAL_INVESTIGATOR
Florida International University
Locations
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James P. Grant School of Public Health BRAC University
Dhaka, Bir Uttom A K Khandakar Road, Bangladesh
Countries
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References
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Provided Documents
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Document Type: Statistical Analysis Plan
Related Links
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The Fred Hollows Foundation. (2023). Closing the gender gap in eye health in Bangladesh
Orbis International. (2023). Closing the gender gap in eye care across Banglades
Other Identifiers
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MHLS 22_69
Identifier Type: -
Identifier Source: org_study_id