Determining trustworthiness and safety of remote consulting during the COVID-19 pandemic in primary healthcare for chronic disease populations in Nigeria and Tanzania

Not Applicable

Completed

• Conditions: Chronic disease, type 2 diabetes, hypertension, chronic obstructive pulmonary disease, coronary heart disease; Not Applicable

• Registration Number: ISRCTN17941313
• Lead Sponsor: King's College London

Brief Summary

2023 Abstract results in https://doi.org/10.1016/j.diabres.2023.110484 Abstracts from the IDF World Diabetes Congress 2022 - 0837 (added 07/06/2023) 2023 Results article in https://doi.org/10.1016/s2214-109x(23)00411-4 (added 20/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-20
• Study Completion: 2022-03-31
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12022

Inclusion Criteria

1. Receiving healthcare from participating primary care facilities
2. Able to speak, read and write in English or local language
3. Give consent to participate in the study
4. Aged =18 years
5. Receiving treatment and/or monitoring for =1 of the following conditions:
5.1. Type 2 diabetes
5.2. Hypertension
5.3. Chronic obstructive pulmonary disease
5.4. Coronary heart disease
6. Contact with health facility =3 times per year

Exclusion Criteria

1. No access to a mobile phone or fixed phone in the community
2. Identified by health workers as nearing the end of life or currently severely ill
3. Carers consulting on another person’s behalf
4. Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Patient trust in healthcare provider measured using the Physician Humanistic Behaviour Questionnaire (PHBQ) at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months <br>2. Face to face consultation rate defined as the number of visits per month for the eligible patient population where the patient is seen in person by the consulting health worker measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months <br>3. Remote consultation rate defined as the number of visits per month for the eligible patient population conducted using a telephone measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months <br>4. Prescribing rate defined as the number of prescriptions issued and collected to the eligible patient population per month. This outcome is a proxy for patient safety as a change in this outcome is an indicator of changes in safety and confidence measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months

Secondary Outcome Measures

Name	Time	Method
1. Patient engagement with their health measured using the Patient Activation Measure (PAM-13) at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months <br>2. Patient safety assessed from the number of investigations processed by the facility monthly, matched to the patient’s consultation type (where an increase may indicate a higher safety threshold when the person cannot be examined, and a decrease may indicate missed health needs) measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months