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Integrating technology-assisted diabetes foot care in Pakistan

A feasibility cluster randomised controlled trial of technology-assisted diabetes foot care in Pakistan

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16377491
Enrollment
320
Registered
2024-10-01
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Diabetes Nutritional, Metabolic, Endocrine

Interventions

Health facilities will be randomized into control and intervention. Healthcare staff will be enabled to offer enhanced foot care and footwear intervention. The enabling includes contextualized implem
flip book for patient education
b) materials for foot care and footwear, e.g., silicone rubber insoles
c) digital mobile app for patient engagement including knowledge content and platform to report social and care challenges. In addition to these components: Periodic follow-up screening and response

Sponsors

Association for Social Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 25 years or older 2. Registered for diabetes care at the primary health care facility 3. Willing to provide written informed consent 4. Have access to a smartphone (i.e., personal smartphone or access to a smartphone within the household)

Exclusion criteria

Exclusion criteria: 1. Diabetes patients who plan to move out of the RHC catchment area during the study period 2. Refuse to give consent to participate

Design outcomes

Primary

MeasureTime frame
The feasibility of clinical outcomes: 1. Uptake of recommended foot care behavior is measured through Nottingham Assessment of Functional Footcare (NAFF) at baseline and endpoint 2. Quality of life is measured through European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) at baseline and endpoint 3. Uptake of follow-up footcare visits is measured through non-communicable disease card (NCD) card at every follow-up. 4. Uptake of mobile-app-assisted patient engagement measured through application analytics (such as average time spent) at endpoint 5. Uptake of referral care at DHQ hospital through digital referral application (i.e., number of patients referred and reached DHQ) at endpoint 6. Deterioration in foot condition/stage will be measured through non-communicable disease card (NCD) card at baseline and endpoint 7. Complications during footcare (necrosis, amputation, hospitalization) will be measured through non-communicable disease card (NCD) card at baseline and endpoint

Secondary

MeasureTime frame
The feasibility of operational and economic outcomes: Operational outcomes: 1. Patient enrolment – OPD load; diabetes patient load; refusal to participate in footcare intervention will be measured through monitoring reports 2. Patient adherence to footcare follow-up (till endline) will be monitored at every follow-up Economic outcomes : Providers' cost of RHC enabling, footcare per patient, desired outcome (of footcare) and additional emergency/catastrophic costs will be measured through program data at endpoint

Countries

Pakistan

Contacts

Public ContactNida Khan
nida.khan@conted.ox.ac.uk+92 (0)3215303632

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026