Transforming Households With Refraction and Innovative Financial Technology

Presbyopia Clinical Trial

— THRIFT  

Official title:

A Randomised Controlled Trial on the Impact of Free Reading Glasses to Support Use of Smartphone Banking in Bangladesh Among Government Old Age Allowance and Widow Allowance Beneficiaries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510687
• Other study ID #: MHLS 22_69
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Queen's University, Belfast
• Contact: Nathan G Congdon, MD, MPH
• Phone: +44(0)2890978929
• Email: n.congdon[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the proposed Randomised Clinical Trial (RCT) is to assess the impact of presbyopia correction and basic digital financial training on greater adoption and use of digital financial services (primary outcome) and other welfare impacts (secondary outcomes)) for safety-net beneficiaries in Bagladesh. Trial participants will be Old Age Allowance (OAA) and Widows Allowance (WA) beneficiaries who regularly receive payments as part of a government safety net program for the very poor.

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 and the THRIFT app (a module locally developed to capture digital financial transactions) 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 External remittances, recorded on the bKash app and captured in survey Self-reported incidence of theft or fraudulent use of money from the index participant's account.

Description:

Background and Rationale: The proliferation of mobile banking systems across developing countries has provided previously un-banked populations with a convenient method to manage their finances digitally. The Government of Bangladesh launched the Old Age Allowance (OAA) and Widow Allowance (WA) programmes in 1998 to provide a financial safety net to its poor and vulnerable population - elderly under OAA and vulnerable women under WA. More than half of Bangladeshi adults lack access to a formal bank account, with most of the un-banked population belonging to the poorest 40% of households. Mobile money, through applications such as bKash, has become the "innovation" to improve the financial inclusion scenario in Bangladesh, especially during the coronavirus pandemic. The take-up of mobile money is often limited by a lack of technical awareness and trust concerns among the elderly. Lee at al. (2021) have addressed these concerns through an intervention consisting of initial training and subsequent minor assistance in using the bKash mobile banking application, which they randomised over a sample of poor households in rural Bangladesh. They found an increase of 7.5% in rural consumption, a reduction in extreme poverty and a 26% increase in urban to rural remittances among the sample participants using bKash a year after the intervention. Across Low and Middle Income Countries (LMICs), experimental studies encouraging adoption of mobile money applications have been shown to improve consumption smoothing, savings and access to credit. There is evidence to support the theory that a training module introducing the elderly to mobile banking will help bridge strong information and trust gaps, and encourage greater financial independence. As traditional joint family structures weaken in South Asian societies, greater economic independence among older populations has the potential to improve their functional independence, level of healthcare access, and mental well-being. Evidence suggests that there is a substantial burden of uncorrected presbyopia in Bangladesh. Uncorrected vision problems have been found to negatively affect visual function, which includes smart phone and mobile phone usage among the elderly in multiple LMIC contexts. It has also been found to affect productivity among tea plantation workers performing visually demanding tasks in Assam, India. This can lead to lower engagement with mobile banking platforms, which in turn can limit elderly people's access to their finances. Conversely, correction of presbyopia is associated with significant improvements in work productivity and other economically important outcomes.

The proposed THRIFT trial is the first 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. This randomised trial will evaluate whether providing study populations with glasses for presbyopia, and a digital financial training module can significantly improve the use of mobile banking for cash transfers, deposits, and withdrawals, compared to controls receiving these interventions only after end line.

Aim: 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. First follow-up visit one month after receiving glasses and second visit 5 months after the first follow up visit

• to check the compliance to eyeglasses

• Collect any safety event information MOMODa Foundation team conducts 3 follow-up visits per participant at 3, 6 and 9 months after providing the smartphones and training. 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 12 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 (Mogolbasa, Belgacha, Ghogadoho, Holokhana, Jatrapur, Panchgachi, and Vogdanga) and two in Nageshwari (Bhitorbond and Hasnabad).

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 with approximately ten beneficiaries per day, aiming to meet their survey target.

MF will conduct a door-to-door social screening survey based on the eligibility criteria. Upon receiving the beneficiaries' consent to participate in the study, the following screening procedures are done.

1. It is important that THRIFT only include those that have incomes at or below the government's eligibility criteria. This will be determined by means of a standardized brief Wealth Index questionnaire "Equity Tool" which is a simplified form generated from the DHS

2. Internet Connection: An internet speed of 13 kbps is found to be optimal to incorporate the data into the social screening survey interface.

3. 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.

The score from the app will be used to assess the individual's basic cognitive capacity as well. Cut off value for eligibility in the NDC app is considered 8 or more.

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.

4. An application called "THRIFT app" has been developed to collect transaction information related to mobile banking who use the DFS service via their mobile phones. This app facilitates the gathering and storage of mobile banking transaction data on a server through an internet connection. When the beneficiaries receive a mobile phone from MF, the THRIFT app will be pre-installed on their mobile device.

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.

Sequence generation The randomization sequence will be generated by the study statistician at the 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 JPGSPH and will be accessed by the concealment implementers only.

Implementation 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 to analyze most outcomes. This would involve regressing the outcome of concern on the randomised intervention status, outcome level as recorded at baseline or Analysis of Covariance (ANCOVA ) estimation (if available), and a vector of baseline control variables.

All analyses will be adjusted for age, gender, and previous phone use. 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 application-based financial transaction data) will be aggregated (either monthly or weekly) where errors will be 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 571
• Est. completion date: June 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age

• 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 Lives in the bKash catchment area, Kurigram

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 MFS account by themselves

Exclusion criteria

1. Poor internet connection, less than 13kbps

2. Presence of any cause of near or distance vision impairment that cannot be resolved with presbyopic glasses.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Glasses to correct presbyopia
Participants will receive eyeglasses to correct presbyopia, as per the power determined in the eye examination.

Locations

Country	Name	City	State
Bangladesh	James P. Grant School of Public Health BRAC University	Dhaka	Bir Uttom A K Khandakar Road

Sponsors (8)

Lead Sponsor	Collaborator
Queen's University, Belfast	BRAC University, Clearly, Florida International University, Good Business Labs Foundation, L.V. Prasad Eye Institute, MOMODa Foundation, VisionSpring

Country where clinical trial is conducted

Bangladesh, 

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of transactions with the index bank account per unit time.	This will be calculated using THRIFT and bKash app. THRIFT app will capture incoming transaction of two leading DFS bKash and Nagad transactions. It will record the number of bank transactions undertaken through the DFS app, as they will reflect in the Short Message Service (SMS) on the participants' phone. On the other hand, bKash transaction level data will provide both incoming and outgoing transactions.	Once every week
Secondary	Application was facilitated by a bKash agent or family member, or independent	Whether use of the application was facilitated by a bKash agent or family member, or independent. A binary outcome with either Yes or No	Change from baseline to 12 months
Secondary	Purchase of additional phones by study participant's household	The number of mobile phones purchased per household is assessed. A binary outcome with either Yes or No	Change from baseline to 12 months
Secondary	Purchase of additional phones by study participant	The number of mobile phones purchased by the individual is assessed. A binary outcome with either Yes or No	Change from baseline to 12 months
Secondary	Intra-household resource sharing by the beneficiary	Percentage of resource shared by the beneficiary from total household consumption. Best score is 100 and worst score is 0.	Change from baseline to 12 months
Secondary	Purchase of glasses	Glasses purchased by the study participant. A binary outcome with either Yes or No.	Change from baseline to 12 months
Secondary	Food security	Participants perception of the nutrition and quantity of their daily food consumption is measured. This is a continuous index with larger values indicating higher levels of food insecurity.	Up to 12 months
Secondary	Role of study participant in household decision making autonomy	The onus of decision making for different household activities by the participant is assessed using a survey instrument developed fort the trial. Best score is 100% and worst score is 0%	Change from baseline to 12 months
Secondary	Subjective well-being of study participants	Participants satisfaction with various aspects of their life such as their health and personal relationships is assessed using the World Health Organisation Quality of Life survey. Best score is 100 and worst score is 0.	Change from baseline to 12 months
Secondary	Mobility of study participant	Participants comfort in regular physical activities is assessed using Global Physical Activity Questionnaire. Self-reported physical activity.	Change from baseline to 12 months
Secondary	Social connectedness of study participant	Participants engagement with their family members, friends and neighbors is assessed using Social Networking Index. The best possible score is 12 and the worst possible score is 0.	Change from baseline to 12 months
Secondary	External remittances, recorded on the bKash app	Participants banking habits; if they have an account with a formal banking institution, their awareness of mobile money transactions and the various methods & constraints in the way of undertaking mobile banking'are assessed with worst score being 0. Higher values indicate frequent remittances.	Once in a month.
Secondary	Incidence of theft or fraudulent use of money	Self-reported incidents on theft from the index participant's bank account. A binary outcome with either Yes or No	Up to 12 months