農村住民における老眼解消の生産性研究 III (PROSPERIII)
インドの繊維工場労働者の仕事保持に対する近方視力矯正の効果
The investigators will conduct an embedded mixed methods study in which the primary approach is a randomized controlled trial (RCT), and the secondary or embedded approach is a descriptive qualitative study. The aim of the RCT is to assess the impact of presbyopic correction on workplace productivity and retention in the textile industry in a low middle-income country. Additional qualitative data will be collected to enhance understanding of factors linked to reasons why enrolled sew-ers left their job during the study. Participants will be textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India.
調査の概要
詳細な説明
Globally, 1.1 billion people lack a simple pair of reading glasses to correct impaired near vision, called presbyopia. Presbyopia can begin as early as age 30 years, commonly becomes functionally apparent by 40, and is essentially complete by 55 meaning that presbyopia is most common at the height of the working years. The global productivity loss due to uncorrected presbyopia has been estimated to exceed US$25 billion, and presbyopia is shown to be associated with significant impairment in activities of daily living. There is paucity in trial evidence of the impact on near vision spectacle correction on work productivity and workplace retention. The largest reported effect sizes among such trials (specifically for productivity) was the PROSPER trial, which showed that providing inexpensive near vision glasses increased the daily weight of tea picked among presbyopic, mostly-female Indian agricultural workers by more than 5 kg (21.7%) compared to those in the control group.
Study Plan: The investigators will choose 1260 textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India. They will be randomly assigned into one of two groups: a group receiving free reading glasses within one week of undergoing vision assessment ("Intervention") or a group receiving identical reading glasses at the end of the assessment period ("Control").The main study outcome will be the proportion of workers who continue working at the factories in the intervention group (as opposed to control). The investigators anticipate that the glasses intervention will increase retention by 20% in the Intervention group at 1 year.
The study will also assess the workers' efficiency, why they have left employment, how satisfied and valued they felt at their work and how often they use their glasses for work. These other outcomes will help the investigators to better understand the causal pathway between vision and work retention. The investigators will also study the total cost of providing glasses per additional worker retain their employment.
Research question: Will providing free glasses to presbyopic Indian textile workers increase work retention?
Design: Investigator-masked, multi-center randomized controlled trial with a qualitative component
Rationale: Although presbyopia is safely, effectively and inexpensively treated with glasses, rates of optical correction in LMICs are as low as 10%. The way in which firms manage workers has profound implications for performance by way of worker attendance, retention, and productivity. Similarly, worker engagement, and the extent to which workers feel valued, is a key determinant of firm performance. As the low-skill workforce in many developing countries transitions rapidly from agriculture to industrial work, employers struggle with high worker turnover due to poor working conditions, low pay, and restricted worker rights. Few trials have been published which address the question of whether healthcare interventions can improve work performance as well as workplace retention, especially among persons over the age of 40 in low and middle-income countries (LMICs). There is interest in understanding if these results obtained in an agricultural setting can be extended to other financially-important sectors.
Methods: The investigators will choose 1260 textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India. They will be randomly assigned into one of two groups: a group receiving free reading glasses within one week of undergoing vision assessment ("Intervention") or a group receiving identical reading glasses at the end of the assessment period ("Control").
The main outcome 18 month later will be work retention; secondary outcomes are workers' efficiency, the reasons the workers left their employment, satisfaction and perceived self-valued at work and glasses wear adherence at work. Attitudes about presbyopia and spectacle use and intervention cost-effectiveness will be studied.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Karantaka
-
Bengaluru、Karantaka、インド、560102
- Good Business Lab
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 30 years and above
- Distance visual acuity >= 6/12 in both eyes
- Presence of presbyopia, defined as the inability, correctable with reading glasses, to read the N8 line using both eyes together, on a tumbling near vision chart at a distance of 25cm, 30cm, 40cm, and 50cm based on workers working distance
- Employed at the factory for >=3months in the sewing department
Exclusion Criteria:
- Current ownership of reading or distance glasses (regardless of accuracy)
- Obvious evidence of ocular disease in either eye detected during the eye examination, or history of such disease based on self-report
- Low likelihood of completing follow-up in the study due to current plans to move out of the area or leave employment at Shahi during the follow-up period
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Intervention
Workers assigned to the intervention group will receive free spectacles of a design they select, based on the worker's measured refractive power and dispensed one week later at the factory by the study ophthalmic personnel. |
Intervention group workers receive free glasses within one week of undergoing vision assessment (May 2022). The duration of the treatment for the Intervention participants will depend on when they leave employment at the factor. If they stayed for the full duration of the trial, they will have undergone a maximum of 18 months (December 2023).
他の名前:
|
|
介入なし:Control
Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (18 months). |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Work retention
時間枠:September 2022 to May 2024; Over the 18 month follow-up period from enrolment to study completion
|
Proportion of textile workers who continue to work at the textile factories assessed from trial entry to closure as recorded in Shahi's Human Resource Management Database |
September 2022 to May 2024; Over the 18 month follow-up period from enrolment to study completion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compliance with spectacle wear
時間枠:3, 6, 9, 12, 15 and 18 months after enrolment
|
Actual presence of spectacles on the worker's face at work as reported by supervisor at the time of unannounced observation |
3, 6, 9, 12, 15 and 18 months after enrolment
|
|
Change in work satisfaction
時間枠:Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
Proportion of sew-ers who state they are satisfied or very satisfied with work, feel valued or very valued at work, and are likely or very likely to stay with Shahi |
Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
|
Change in feeling valued-at-work
時間枠:Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
Proportion of sew-ers who state they feel valued or very valued working at Shahi |
Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
|
Change in likeliness to stay at work
時間枠:Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
Proportion of sew-ers who state they are likely or very likely to stay with Shahi |
Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
|
Change in work efficiency
時間枠:Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
Self-assessed productivity scores using the Cantril's Ladder, with the best possible score being a 10, and the worst being a 0. |
Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
|
Attitudes towards vision correction
時間枠:At month 0
|
Worker's self-reported attitudes towards vision correction |
At month 0
|
|
Access to local eyecare services
時間枠:At month 0
|
Worker's self-reported access to local eyecare services |
At month 0
|
|
History of uptake of eyecare services
時間枠:At month 0
|
Worker's self-reported history of uptake of eyecare services |
At month 0
|
|
Change in Quality of Life as assessed by the THRIVE Near Vision Quality of Life tool
時間枠:Between baseline and endline at 18 months
|
Self-reported quality of life scores measured with the modified THRIVE Near Vision Quality of Life tool, a Likert Scale ranging from 1 (least affected) to 5 (worst affected). |
Between baseline and endline at 18 months
|
|
Reasons leaving employment at Shahi
時間枠:2 months within participants leaving employment
|
Reasons given by the former supervisor and colleagues of former sew-ers for workers no longer being employed at Shahi |
2 months within participants leaving employment
|
|
Change in work productivity
時間枠:Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
Proportion of target production realized by a worker per unit time. |
Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
|
|
Cost effectiveness of intervention
時間枠:At study closeout at 18 months
|
Ratio of incremental program cost to additional workers in the intervention group who retain employment vs. those in the control group. Incremental cost is the difference of program costs between implementation of intervention and control (not including study costs, such as data collection). |
At study closeout at 18 months
|
|
Change in skill grade
時間枠:Between baseline and endline at 18 months
|
Worker's skill grade as reported by supervisor. |
Between baseline and endline at 18 months
|
|
Change in monthly wage
時間枠:Between baseline and endline at 18 months
|
Worker's monthly wage as reported by supervisor. |
Between baseline and endline at 18 months
|
協力者と研究者
協力者
捜査官
- 主任研究者:Nathan G Congdon, MD, MPH、Queen's University, Belfast
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。