Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201701001964199 Date of Approval: 06/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the effectiveness of telemedicine in the management of risk and cardiovascular problems in primary health care in Cameroon
Official scientific title Evaluation of the effectiveness of telemedicine in the management of risk and cardiovascular problems in primary health care in Cameroon
Brief summary describing the background and objectives of the trial This study was developed in order to bring out our contribution to the issue of evaluating e-Health and telemedicine in developing countries and to respond more specifically to the question of the effectiveness of tele-expertise (tele-ECG) in developing countries. The general objective of this study is to evaluate the effectiveness of tele-ECG in primary health care in Cameroon for the management of patients with cardiovascular problems or risk factors. The specific objectives are to: (i) improve the clinical processes of health professionals; (ii) improve the clinical outcomes of patients (participants); (iii) evaluate satisfaction of participants and health professionals.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) EEET Study
Disease(s) or condition(s) being studied Cardiovascular Diseases, Telemedicine,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/04/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 30/12/2016
Actual Last follow-up date 30/01/2017
Anticipated target sample size (number of participants) 182
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised The cluster pairing mode (district or health area) was chosen rather than the individual mode. There was no cluster randomization because two telemedicine (intervention) sites already existed before the start of the study. In each health center (intervention or control), patients were gradually recruited by health professionals. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention sites 3 months for each patient Participants with a cardiovascular risk factors or problems received routine care by a general practitioner or nurse. There was proposed to the participants to do the on-site prescribed ECG examination. After, a request via a tele-expertise platform for remote expertise was made by local healthcare professional to a medical specialist (cardiologist) for remote expertise. 91
Control Group Control sites 3 months for each patient Participants with a cardiovascular risk factors or problems received usual care by a general practitioner or nurse, namely: a conventional clinical examination, requests for diagnostic tests, management and scheduling appointments. A recommendation of a consultation at a cardiology center or to see a cardiologist was addressed to all participants. No tele-ECG or no remote support via tele-expertis 91 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligible participants must meet at least one of the following inclusion criteria are: i. Present with one or more of the following Cardiovascular risk factors: age (¿ 45 years for men and ¿ 55 years for a woman); active smoking (¿ 1 cigarette / day) arterial hypertension (¿ 140/90 mmHg or on antihypertensive treatment); fasting hyperglycemia (fasting blood sugar > 1.1 g / l) or diabetes; obesity (body mass index ¿ 30 kg / m2; truncal obesity (men ¿ 102 cm, female: ¿ 88 cm). ii. History of cardiovascular disease (personal or first degree family history) iii. Present with symptoms (dyspnoea, palpitations, chest pain, etc.) or signs (tachy -bradycardia, heart murmur, edema, arterial hypo-hypertension, etc.) making suggestive of a cardiovascular disease. iv. Residing in the health area or district with the corresponding health structure in which he/she consults and provides an address in which he can be reached in case of need, v. Give informed consent (sign the form) after an explanation by the health care professional on the goals of the study. vi. Finally, in the intervention centers, participants will also have to do an ECG examination. Hospitalised patients or patients deemed severely ill by a health professional will be excluded from this study. 18 Year(s) 100 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/08/2016 Centre Regional Ethics Committee for Human Health Research
Ethics Committee Address
Street address City Postal code Country
Rond point Nlongkak Yaoundé Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Participants¿ access to an ECG examination and expertise At end of the project
Secondary Outcome ECG requested At the end
Secondary Outcome ECG request time At the end
Secondary Outcome Expertise response time At the end
Secondary Outcome Diagnostic discordance At the end
Secondary Outcome Inappropriate medical prescriptions At the end
Secondary Outcome Applicability of the expert's recommendations At the end
Secondary Outcome Incorrect Evacuation (unnecessary / necessary) At the end
Secondary Outcome Centers¿ Attendance Rate At the end
Secondary Outcome Compliance to prescribed treatment At 3 months
Secondary Outcome Evolution of clinical symptoms At 3 months
Secondary Outcome Evolution of the blood pressure At 3 months
Secondary Outcome Overall satisfaction of participants At 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Akonolinga District Hospital Akonolinga Cameroon
Foumbot District Hospital Foumbot Cameroon
Sa'a District Hospital Sa'a Cameroon
Mbouda District Hospital Mbouda Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
RAFT Network (http://raft.g2hp.net/) Rue Gabrielle-Perret-Gentil 4, Genève 1205 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine of Biomedical Sciences of University of Yaoundé 1 Melen Yaoundé 1364 Cameroon University
COLLABORATORS
Name Street address City Postal code Country
Georges Bediang Melen Yaoundé Cameroon
Yannick Kamga Melen Yaoundé Cameroon
Chris Nganou Melen Yaoundé Cameroon
Jean Serge NDONGO Melen Yaoundé Cameroon
Cheick Oumar Bagayoko Bamako Mali
Samuel Nko 'o Melen Yaoundé Cameroon
Antoine Geissbuhler Rue Gabrielle-Perret-Gentil 4, Genève 1205 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Georges Bediang bediang@yahoo.com +237 699 58 85 74 Melen
City Postal code Country Position/Affiliation
Yaoundé 1346 Cameroon Research et Teatching Assistant at Faculty of Medicine and Biomedical Sciences
Role Name Email Phone Street address
Public Enquiries Yannick kamga yannick_kamga@yahoo.fr +237 699 59 89 20 Quartier du Lac
City Postal code Country Position/Affiliation
Yaoundé Cameroon Public Health Specialist at the Ministry of Public Health (Cameroon)
Role Name Email Phone Street address
Scientific Enquiries Georges Bediang bediang@yahoo.com +237 699 58 85 74 Melen
City Postal code Country Position/Affiliation
Yaoundé 1346 Cameroon Research et Teatching Assistant at Faculty of Medicine and Biomedical Sciences
REPORTING
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