Transforming Households With Refraction and Innovative Financial Technology

NCT05510687 | Active Not Recruiting DMC

• 1 other identifier: MHLS 22_69
• Study Type: interventional
• Target: 571
• Locations: 1 country
• Sites: 1

Brief 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 Bangladesh. 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 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 data consumption, independent use of the mobile banking application, purchase of eyeglasses (for control group members), access to medication and healthcare, subjective well-being, mobility, social connectedness, percentage of household consumption, reasons for using or avoiding smartphone based DFS, and decision-making power within the household.

Conditions

Presbyopia

Keywords

Presbyopia; Digital transactions and vision

Outcome Measures

Primary Outcomes (1)

• Change in the average number, difference in the mean value, difference in the mean total value of transactions per participant per quarter comparing a 12-month period before the intervention to a 18-month period after the intervention

  This will be calculated using both the incoming and outgoing transaction level data from bKash.

  Once every quarter through study completion (up to 18 months)

Secondary Outcomes (14)

• Application was facilitated by a bKash agent or family member, or independently by the beneficiary.

  Change from baseline to 18 months

• Purchase of additional phones by study participant's household

  Change from baseline to 18 months

• Purchase of additional phones by study participant

  Change from baseline to 18 months

• Intra-household resource sharing by the beneficiary

  Change from baseline to 18 months

• Purchase of glasses other than those issued to the intervention group

  Change from baseline to 18 months

Study Arms (2)

Glasses to correct presbyopia and digital financial training

EXPERIMENTAL

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.

Device: Glasses to correct presbyopia

Control-No treatment

NO INTERVENTION

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.

Interventions

Glasses to correct presbyopia DEVICE

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

Glasses to correct presbyopia and digital financial training

Eligibility Criteria

• Age: 48 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• years old male OAA beneficiaries
• years old female OAA beneficiaries
• years old WA beneficiaries
• Receiving digital OAA or WA payments from the Government of Bangladesh
• Residence Lived in the bKash catchment area, Kurigram for 3 more
• Presbyopia
• Binocular presenting near-vision N6.3 or worse, correctable to N5 or better
• Require a new pair of glasses
• Mapped into bottom three asset quintiles according to the equity tool questionnaire
• Numeracy, dexterity and cognitive ability Score 8 or above on NDC Screening test.
• Individuals who do not use Mobile Financial Services (MFS) account by themselves

You may not qualify if:

• Poor internet connection, less than 13kbps
• Presence of any cause of near or distance vision impairment that cannot be resolved with presbyopic glasses.

Sponsors & Collaborators

• L.V. Prasad Eye Institute: collaborator
• VisionSpring: collaborator
• MOMODa Foundation: collaborator
• Good Business Labs Foundation: collaborator
• Florida International University: collaborator
• Clearly: collaborator
• BRAC University: collaborator
• Queen's University, Belfast: lead

Study Sites (1)

James P. Grant School of Public Health BRAC University

Dhaka, Bir Uttom A K Khandakar Road, 1213, Bangladesh

Location

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Related Links

• 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

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Nathan G Congdon, MD, MPH

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

• Atonu Rabbani, PhD

  BRAC James P Grant School of Public Health

  PRINCIPAL INVESTIGATOR

• Abu S Shonchoy, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The trial will be investigator-masked, but Community Health Workers (CHW), other fieldwork personnel and the participants will not be masked to Intervention Group assignment. This is because participants in the Intervention Group will receive eyeglasses at the start of the trial and members of the Control Group will receive theirs at the end. All care will be taken to ensure that the investigators who are not involved in fieldwork will be kept masked, and they do not foresee conditions that will require emergency unmasking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: THRIFT is a randomised controlled trial (RCT) that employs an explanatory embedded mixed methods design whereby the RCT is the primary study, and the secondary or embedded approach is a mixed-methods investigation of the culture and context surrounding the trial. The basic RCT design employs individual OAA and WA beneficiary-households in digitised safety-net catchment areas as the unit of randomization. The study uses a two-arm RCT design, one treatment and one control arm. Only households with an eligible participant who does not personally own a smartphone or feature phone and .access DFS through any phone during the time of the trial. The duration of the RCT is 18 months. The trial will be investigator masked.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: December 10, 2023
• Primary Completion: September 8, 2025
• Study Completion: April 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: All deidentified IPD will be available from January 2023 (anticipated Trial start date) to Aug 2024 (inclusive of analysis, report writing and publication).
• Access Criteria: Following publication of the primary and secondary outcomes there may be scope to conduct additional analyses on the data collected. In such instances formal requests for data will need to be made in writing to the Chief Investigator, who will discuss this with the Sponsor. The study will comply with the good practice principles for sharing individual participant data from publicly funded clinical trials and data sharing will be undertaken in accordance with the required regulatory requirements.

Locations

BA (1)