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Transforming Households With Refraction and Innovative Financial Technology (THRIFT)

Primary Purpose

Presbyopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Glasses to correct presbyopia
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Digital transactions and vision

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age

    1. 65-70 years old male OAA beneficiaries
    2. 62-70 years old female OAA beneficiaries
    3. 50-60 years old WA beneficiaries
  2. Presbyopia

    a. Untreated

  3. Numeracy a. Basic numeracy ability
  4. Cognition

    a. cognitive ability

  5. Dexterity a. basic dexterity

Exclusion Criteria:

  1. OAA/WA beneficiaries

    a. not eligible as assessed by the means testing criteria

  2. Benefits

    a. already receiving benefits through a digital banking app

  3. Other eye problems a. Presence of other eye problems like cataract
  4. Vision

    a. Poor vision problem

  5. Communication

    a. inability to communicate clearly in Bangla

  6. Informed consent a. Not willing to give informed consent

Sites / Locations

  • James P. Grant School of Public Health BRAC University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Glasses to correct presbyopia and digital financial training

Control-No treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of transactions with the index bank account per unit time.
A change in the bKash balance sheet measured on the THRIFT app indicating a transaction undertaken using mobile banking. A higher number indicates a more frequent transaction
Number of interactions with the mobile banking app per unit time
The number of times the bKash app is opened on a phone. A higher number indicates a more frequent interaction.

Secondary Outcome Measures

Total mobile data consumption by the individual
Total data consumed by the participant during the study period. A higher value indicates more usage of the internet.
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
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
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
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.
Purchase of glasses
Glasses purchased by the study participant. A binary outcome with either Yes or No.
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.
Adequate and timely access to healthcare and medications
Assessed by self-reported measures of purchase of essential medicine and healthcare visits. Best score is 5 and worst score is 1 on a 5-point Likert scale.
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%
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.
Mobility of study participant
Participants comfort in regular physical activities is assessed using Global Physical Activity Questionnaire. Self-reported physical activity.
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.
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.
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

Full Information

First Posted
August 18, 2022
Last Updated
August 2, 2023
Sponsor
Queen's University, Belfast
Collaborators
L.V. Prasad Eye Institute, VisionSpring, MOMODa Foundation, Good Business Labs Foundation, Florida International University, Clearly, BRAC University
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1. Study Identification

Unique Protocol Identification Number
NCT05510687
Brief Title
Transforming Households With Refraction and Innovative Financial Technology
Acronym
THRIFT
Official Title
A Randomised Controlled Trial on the Impact of Free Reading Glasses to Support Use of Smart Phone Banking in Bangladesh Among Government Old Age Allowance (OAA)/Widow Allowance (WA) Beneficiaries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
L.V. Prasad Eye Institute, VisionSpring, MOMODa Foundation, Good Business Labs Foundation, Florida International University, Clearly, BRAC University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 an Low to Middle Income Countries (LMIC). 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 independent 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 Food security (measured using standard module developed by World Food Programme (WFP) Adequate and timely access to healthcare and medications (self-reported measures of purchase of essential medicine and healthcare visits.) Role of study participant in household decision making autonomy (measured using a standard survey instrument). Subjective well-being of study participants (self-reported measures using a standard survey module). Mobility of study participant Social connectedness of study participant External remittances, recorded on the bKash app (verified by survey) Self-reported incidence of theft or fraudulent use of money from the index participant's account.
Detailed 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. Study Plan: List of OAA/WA beneficiaries from Department of Social Services (DSS) is obtained and the beneficiary list is screened for eligibility by MOMODa Foundation. Consent for Social screening is obtained by Community Health workers (CHW) of MOMODa Foundation and consented participants are assigned the Unique participant Identifier(ID). All the relevant documents are verified and social screening 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 MOMODa Foundation for proceeding with baseline survey followed by randomisation. Treatment group gets the eyeglasses, mobile phone and training on the usage of the mobile banking application. Control group gets mobile phone and prescription for glasses Glasses 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 receiving glasses to check the compliance of eyeglasses. MOMODa Foundation team conducts 3 follow-up visits per participant to check the smart phones provided and to know the comfort of the participant while using smart phone and also to know whether smart phone is being used by the participant. Study Setting: The primary setting will be the rural and peri-urban areas in one of the three districts, namely, Kurigram, Lalmonirhaat and Sherpur in Bangladesh. All these three districts are catchments areas for bKash, a mobile-based financial services platform by which users can make payments and transfers using a mobile phone. Recruitment: This will begin with the receipt of the list identifying OAA and WA beneficiaries living in Kurigram, Lalmonirhaat and Sherpur districts from the Department of Social Service, Ministry of Social Welfare, Government of Bangladesh. Whenever possible, the first contact with the beneficiaries through the local community leaders will be generated. The enumerators will first conduct a test to assess their poverty status and a numeracy and dexterity test to confirm a basic ability to understand the training module and manage simple financial functions on a mobile device. Relatively well-off beneficiaries will be screened out using the means tests. Subject to the consent for the eye examination and other eligibility tests, respondents meeting the eligibility criteria at the first stage, will undergo an eye examination/screening to determine if they have presbyopia. Upon getting a presbyopia diagnosis, individuals who qualify all inclusion criteria and do not meet the exclusion criteria, will be informed about the study, and consented for participation. Those who consent to be in the study will be randomly assigned to the study intervention or control group. VisionSpring and MOMODa Foundation will conduct a home visit three months after dispensing the eyeglasses and mobile phone, respectively for compliance checks. The end-line visit will be conducted after the 12th month of intervention (after beneficiaries received four quarterly transfers from the government). RANDOMISATION AND PROCEDURES Participants will be randomly assigned to either the Intervention or Control Group. Participants in the former will receive a mobile phone with the preloaded bank transaction tracking app, eyeglasses to correct presbyopia, and mobile banking training. Participant in the control group will receive the same model mobile phone with preloaded bank transaction tracking app at the same time as the treated group. They will receive eyeglasses at the end of the trial. 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. This vector would include control variables such as age, gender, educational achievement and household size. The rates of mobile banking usage, as measured in the primary outcomes, will be compared across groups of participants defined 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. Remittances between the two groups will be analysed using the ITT method but without using the ANCOVA specification discussed above. 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), Urban or 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, Digital transactions and vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 /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 smart phone or feature phone and currently is not receiving benefits using Digital Financial Services( DFS) will be eligible to join the trial. The trial will be investigator-masked. The study will run for 16 months, starting with recruitment and screening of potential participants, and ending once participants have completed 12 months of follow up and data collection.
Masking
Investigator
Masking Description
The trial will be investigator-masked, but Community Health Workers, other study 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 researchers are kept masked, and they do not foresee conditions that will require emergency unmasking.
Allocation
Randomized
Enrollment
484 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glasses to correct presbyopia and digital financial training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control-No treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Glasses to correct presbyopia
Intervention Description
Participants will receive eyeglasses to correct presbyopia, as per the power determined in the eye examination.
Primary Outcome Measure Information:
Title
Number of transactions with the index bank account per unit time.
Description
A change in the bKash balance sheet measured on the THRIFT app indicating a transaction undertaken using mobile banking. A higher number indicates a more frequent transaction
Time Frame
Once every week
Title
Number of interactions with the mobile banking app per unit time
Description
The number of times the bKash app is opened on a phone. A higher number indicates a more frequent interaction.
Time Frame
Once every week
Secondary Outcome Measure Information:
Title
Total mobile data consumption by the individual
Description
Total data consumed by the participant during the study period. A higher value indicates more usage of the internet.
Time Frame
Once every month
Title
Application was facilitated by a bKash agent or family member, or independent
Description
Whether use of the application was facilitated by a bKash agent or family member, or independent. A binary outcome with either Yes or No
Time Frame
Change from baseline to 12 months
Title
Purchase of additional phones by study participant's household
Description
The number of mobile phones purchased per household is assessed. A binary outcome with either Yes or No
Time Frame
Change from baseline to 12 months
Title
Purchase of additional phones by study participant
Description
The number of mobile phones purchased by the individual is assessed. A binary outcome with either Yes or No
Time Frame
Change from baseline to 12 months
Title
Intra-household resource sharing by the beneficiary
Description
Percentage of resource shared by the beneficiary from total household consumption. Best score is 100 and worst score is 0.
Time Frame
Change from baseline to 12 months
Title
Purchase of glasses
Description
Glasses purchased by the study participant. A binary outcome with either Yes or No.
Time Frame
Change from baseline to 12 months
Title
Food security
Description
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.
Time Frame
Up to 12 months
Title
Adequate and timely access to healthcare and medications
Description
Assessed by self-reported measures of purchase of essential medicine and healthcare visits. Best score is 5 and worst score is 1 on a 5-point Likert scale.
Time Frame
Change from baseline to 12 months
Title
Role of study participant in household decision making autonomy
Description
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%
Time Frame
Change from baseline to 12 months
Title
Subjective well-being of study participants
Description
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.
Time Frame
Change from baseline to 12 months
Title
Mobility of study participant
Description
Participants comfort in regular physical activities is assessed using Global Physical Activity Questionnaire. Self-reported physical activity.
Time Frame
Change from baseline to 12 months
Title
Social connectedness of study participant
Description
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.
Time Frame
Change from baseline to 12 months
Title
External remittances, recorded on the bKash app
Description
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.
Time Frame
Once in a month.
Title
Incidence of theft or fraudulent use of money
Description
Self-reported incidents on theft from the index participant's bank account. A binary outcome with either Yes or No
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65-70 years old male OAA beneficiaries 62-70 years old female OAA beneficiaries 50-60 years old WA beneficiaries Presbyopia a. Untreated Numeracy a. Basic numeracy ability Cognition a. cognitive ability Dexterity a. basic dexterity Exclusion Criteria: OAA/WA beneficiaries a. not eligible as assessed by the means testing criteria Benefits a. already receiving benefits through a digital banking app Other eye problems a. Presence of other eye problems like cataract Vision a. Poor vision problem Communication a. inability to communicate clearly in Bangla Informed consent a. Not willing to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan G Congdon, MD, MPH
Phone
+44(0)2890978929
Ext
8929
Email
n.congdon@qub.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Rohit C Khanna, MPH
Phone
914035225600
Ext
5600
Email
rohit@lvpei.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan G Congdon, MD, MPH
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atonu Rabbani, PhD
Organizational Affiliation
BRAC James P Grant School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abu S Shonchoy, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
James P. Grant School of Public Health BRAC University
City
Dhaka
State/Province
Bir Uttom A K Khandakar Road
ZIP/Postal Code
1213
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atonu Rabbani, PhD
Phone
+880-1730-441787
Email
atonu.rabbani@bracu.ac.bd
First Name & Middle Initial & Last Name & Degree
Mrittika Barua, PhD
Phone
+880-2-48812213
Email
mrittika@bracu.ac.bd

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Participant Data (IPD) will be stored in anonymised format. The IPD that includes personal identifiable information will be deleted when the data collection process is complete and before the initiation of data analysis. Only de-identified data will be shared with all the researchers for analysis. The primary analysis will be conducted on all outcome data obtained from all enrolled participants as randomised.
IPD Sharing 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).
IPD Sharing 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.
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