Integrating technology-assisted diabetes foot care in Pakistan
| ISRCTN | ISRCTN16377491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16377491 |
- Submission date
- 27/09/2024
- Registration date
- 01/10/2024
- Last edited
- 30/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The purpose of this study is to explore the feasibility of integrating footcare intervention with diabetes patients at the rural health centre (RHC). This study will also inform how beneficial the foot care intervention will be in the prevention and care of diabetic foot conditions that can lead to serious complications such as foot ulcers and amputations. This research will inform how foot care at RHCs can be made better. The participants will be diabetes patients getting treatment at RHC who will be given foot care i.e., screening, treatment, and patient education.
Who can participate?
The RHC at which diabetic patients are receiving diabetes care has been selected to pilot the integration of diabetes foot care in Punjab. All patients who are registered for diabetes care at the RHC will be invited to participate in this study for 6 months. The patients who will be included in the trial will be those who have access to a smartphone i.e., either a personal phone or a phone of a household member. The patients who plan to move out of the RHC catchment population during the study period will not be offered to take part in this study. Only those who provide consent to participate will be included in the study.
What does the study involve?
This research will be conducted at RHCs. As a part of the study, patients will receive foot assessment at the start and end of the study including self-foot care and quality of life assessment. At some RHCs some patients will also receive foot care and digital application during the study period. Written consent will be obtained from the patients who are willing to participate. The patient data will be collected for a period of 6 months. Any foot care will be given and recorded at the regular monthly visit that the patient makes for their core diabetes. The data from assessment tools will also be collected at the start and end of the study only and this will also be made a part of the regular patient visits. No extra visit will be implied for being a part of the research per se if there is no condition identified that needs treatment at RHC. The participants can ask to withdraw themselves from the study at any time.
What are the possible benefits and risks of participating?
There are no foreseeable disadvantages of participating in the study. The patient records collected will be kept safe in lock and all personal data (i.e., data that can identify the patient) will be removed from the data files. The benefit of taking part in this study is that all patients will get access to foot assessment. Those who receive intervention will also be able to access foot care (i.e., prevention, management, and access to suitable footwear) at the RHC as well. Currently, there is no such facility available at RHC for diabetics. Those getting access to the mobile application will get knowledge about prevention and care and the platform to engage in patient-responsive care by reporting challenges through the app. Additionally, patients in the intervention group will have the reference link for getting diabetic footwear fitted according to patient foot needs. There will be no payment made to the patients for taking part in this research.
Where is the study run from?
The study will be conducted at two randomly selected rural health centres from each of four districts (i.e., eight RHCs) of Punjab, Pakistan.
When is the study starting and how long is it expected to run from?
June 2023 to May 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Nida Khan, nida.khan@conted.ox.ac.uk
Contact information
Public, Scientific, Principal Investigator
House 12, street 48, F-7/4
Islamabad
44000
Pakistan
| Phone | +92 (0)3215303632 |
|---|---|
| nida.khan@conted.ox.ac.uk |
Study information
| Study design | Feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Hospital |
| Study type | Prevention, Screening, Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | A feasibility cluster randomised controlled trial of technology-assisted diabetes foot care in Pakistan |
| Study objectives | The primary objective of the study is to assess the feasibility of clinical outcomes of the intervention package versus the routine care. |
| Ethics approval(s) |
1. Approved 03/09/2024, Oxford Tropical Research Ethics Committee (University of Oxford Research Services, Research Governance, Ethics & Assurance Boundary Brook House, Churchill Drive, Oxford, OX3 7GB, United Kingdom; +44 (0)1865 (2)82106; oxtrec@admin.ox.ac.uk), ref: 560-24 2. Approved 11/08/2023, Association for Social Development, Pakistan IRB (House no. 12, Street 48, F-7/4, Islamabad, 4000, Pakistan; +92 (0)51 2611230-3; irb@asd.com.pk), ref: ASD-EAG-23-001 |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | 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 implementation products: a) desk-guide for doctors; 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 (at RHCs): Patient feet will be screened periodically for foot condition (frequency subject to foot condition). The patients get advised according to their foot condition. Linkage of suitable footwear: patients in the intervention arm will have the reference link for getting diabetic footwear fitted according to patient foot needs. The control arm will receive treatment as usual (TAU) as well as footcare screening done by an external evaluator. The duration of the intervention is 6 months. |
| Intervention type | Mixed |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2023 |
| Completion date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Sex | Both |
| Target number of participants | A total of 320 patients (160 in each arm) would be sufficient to address the study objectives. The researchers will recruit four districts (i.e., two districts per arm) with two randomly selected health facilities from each district. Average cluster size is assumed to be 40. |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 07/10/2024 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
40100
Pakistan
40100
Pakistan
Kot Addu
34050
Pakistan
Jatoi
34050
Pakistan
Roda
41030
Pakistan
Mitha Tiwana
41250
Pakistan
Sarai Sidhu
58100
Pakistan
Abdul Hakeem
58180
Pakistan
Sponsor information
Charity
House 12, Street 48, Sector F-7/4
Islamabad
Islamabad
44000
Pakistan
| Phone | +92 (0)51 2611231 3 |
|---|---|
| asd@asd.com.pk | |
| Website | https://asd.com.pk/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be published in a peer-reviewed journal. The protocol and project updates will also be available on the Open Science Framework. The study findings will be presented at national and international research conferences. These findings will be disseminated in a workshop to all policymakers, i.e., Directorate General Health Services and NCD Disease Control Programme. |
| IPD sharing plan | All personal identifiers will be removed from the data file. The anonymized data will be used for sharing if requested. No individual data will be published anywhere. The analysis will be published in a thesis, and research articles and presented in conferences to share learnings. The anonymised patient data may be shared with journals to support publication. All identifiers will be removed; therefore, no individual can be identified from the data set shared with the journal. The research data will be stored for 5 years after the final publication of the study. After 5 years, research data (hard and soft copy) will be discarded. The hard copy of the NAFF and EQ-5D-5L questionnaires and consent forms will be shredded. The soft copy of patient records, questionnaire and application data will also be deleted. Only hard copies of NCD patient records will remain at RHCs as part of routine patient records to be maintained by facility staff. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 30/09/2024 | No | No |
Additional files
Editorial Notes
30/09/2024: Study's existence confirmed by the Oxford Ethics Committee.
