Complex interventions to implement a diabetic retinopathy care pathway in the public health system in Kerala: a hybrid effectiveness-implementation study (Nayanaadram project)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN28942696

Enrollment

1135

Registered

2018-07-06

Start date

2019-01-01

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic retinopathy Eye Diseases Diabetic retinopathy

Interventions

The interventions will be at 3 levels of care. The study will introduce pragmatic interventions to initiate a DR care pathway across primary, secondary and tertiary care to ensure: 1. DR screening of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: People with diabetes

Exclusion criteria

Exclusion criteria: Patients who do not wish to be screened or treated for diabetic retinopathy

Design outcomes

Primary

Measure	Time frame
The number of people with diabetes that were identified, screened and treated for sight threatening retinopathy, measured at 6 months following the interventions	—

Secondary

Measure	Time frame
Measured at 6 months following the interventions: 1. Effectiveness of intervention at primary care level – increase in uptake of DR screening at FHCs as a result of these interventions 2. Effectiveness of interventions at secondary care level – increase in numbers of people treated for STDR in secondary care 3. Effectiveness of intervention at tertiary care level – increase in numbers of patients referred for treatment as a result of DR screening at FHC 4. Factors determining effectiveness of screening and treatment uptake e.g. age groups, gender, FHC 5. Clinical and cost-effectiveness of training and incentivisation of the ASHA workers - completeness of the NCD register in each FHC and the increase in screening and treatment of DR post-training and incentivisation of the ASHA workers Other outcomes: 6. Prevalence of diabetes in each FHC in comparison to the estimated 1:5 adult population in Kerala presumed to be diabetic 7. Prevalence of other complications of diabetes including those with nephropathy, stroke and myocardial infarction identified through the diabetes register 8. Change in life satisfaction questionnaires after the intervention 9. Treatment outcomes of people with STDR 10. Model based economic analysis of the DR screening and treatment pathway	—

Measure

Time frame

Measured at 6 months following the interventions: 1. Effectiveness of intervention at primary care level – increase in uptake of DR screening at FHCs as a result of these interventions 2. Effectiveness of interventions at secondary care level – increase in numbers of people treated for STDR in secondary care 3. Effectiveness of intervention at tertiary care level – increase in numbers of patients referred for treatment as a result of DR screening at FHC 4. Factors determining effectiveness of screening and treatment uptake e.g. age groups, gender, FHC 5. Clinical and cost-effectiveness of training and incentivisation of the ASHA workers - completeness of the NCD register in each FHC and the increase in screening and treatment of DR post-training and incentivisation of the ASHA workers Other outcomes: 6. Prevalence of diabetes in each FHC in comparison to the estimated 1:5 adult population in Kerala presumed to be diabetic 7. Prevalence of other complications of diabetes including those with nephropathy, stroke and myocardial infarction identified through the diabetes register 8. Change in life satisfaction questionnaires after the intervention 9. Treatment outcomes of people with STDR 10. Model based economic analysis of the DR screening and treatment pathway

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026