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.: PACTR202104860816372 Date of Approval: 07/04/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of educating a diabetic population on foot care in a South African regional hospital
Official scientific title The effectiveness of educating a diabetic population on foot care in a South African regional hospital
Brief summary describing the background and objectives of the trial Improving foot-care knowledge and practice is the foundation of curbing diabetic foot disease and subsequent amputation. The objectives of this study were to, (i) assess current knowledge of foot care and lower limb exercise, (ii) assess the current practice of foot care and lower limb exercise, (iii) educate patients on a simple self-management foot care and exercise module, and (iv), evaluate the effect of the education and exercise programme on the patient’s knowledge and changes in behaviour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 13/01/2020
Actual trial start date 20/01/2020
Anticipated date of last follow up 24/02/2020
Actual Last follow-up date 05/03/2020
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention Module Group Teaching session for 30-mintues on day of recruitment - a pamphlet on foot care knowledge and practice and five lower limb exercises. Baseline treatment in the medical outpatient clinic. The module was taught for 30-minutes in the clinic to each participant Thereafter each exercise was to be done at home twice daily, 30 repetitions each. Participants were retested after 6 weeks. Participants in this group were given, a 30-minute teaching session on foot-care instructions and exercises. Pictures of foot-care practices and the exercises were presented on a pamphlet and provided to each participant. The foot-care practices were explained to each participant while the exercises were demonstrated, practiced, and corrected with each patient. This group also received baseline treatment at MOPD. Participants were advised to follow the instructions on the pamphlet. They were re-tested at 6-weeks at their follow-up appointment at the hospital. 40
Experimental Group Intervention Pamphlet Group Participants were just asked to follow the instructions on the pamphlet. This was not provided to the participants in this group. A pamphlet on foot care practices as instructions were given to this group and participants were requested to follow the instructions on the pamphlet. This group also received baseline treatment from the medical outpatient clinic. 40
Control Group Control Group N/A N/A This group only received baseline treatment in the medical outpatient clinic. Participants were re-interviewed 6-weeks later. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with a diagnosis of Type 2 Diabetes Mellitus on some form of treatment attending Addington Hospital MOPD irrespective of age, race, and gender. All patients with no foot pathology, confirmed by the medical doctor. Patients who provided signed consent to participate. Patients who were able to converse in English or Zulu. All patients that did not present with Type 2 Diabetes Mellitus attending Addington Hospital medical outpatient clinic. Patients with foot pathology. Patients with Type 2 Diabetes Mellitus not on some form of treatment. Patients who refused to give consent. Patients with lower limb fractures. Patients who have had past lower limb surgical intervention including amputations. Patients diagnosed with a mental illness. Patients who were unable to converse in English or Zulu. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 95 Year(s) Both
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 09/01/2020 Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UKZN, Westville Campus, Govan Mbeki Building Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome were changes in foot-care knowledge, practice and exercise scores obtained before and after the intervention. Six weeks later
Secondary Outcome The secondary outcome was the comparisons of the effectiveness of the pamphlet module group to the pamphlet group and the control group. Six weeks later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addington Hospital 16 Erskine Terrace, South Beach Durban 4000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Prabashni Manickum 7 Hillhead Drive Durban 4032 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prabashni Manickum 7 Hillhead Drive Durban 4032 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Professor TE Madiba University of Kwa-Zulu Natal Durban 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Prabashni Manickum Prabashni1@gmail.com 27848181846 7 Hillhead Drive
City Postal code Country Position/Affiliation
Durban 4032 South Africa Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Thandinkosi Madiba MADIBA@ukzn.ac.za +27828069930 UKZN, Department of Surgery, Nelson R. Mandela, School of Medicine
City Postal code Country Position/Affiliation
Durban 4000 South Africa Emeritus Professor of Surgery
Role Name Email Phone Street address
Public Enquiries Serela Ramklass ramklasss@ukzn.ac.za +27826548936 UKZN, School of Clinical Medicine
City Postal code Country Position/Affiliation
Durban 4000 South Africa Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results of the study will be shared. Individual participant data will be made available following publication of the article. Informed Consent Form,Statistical Analysis Plan,Study Protocol All documents and data will be available following publication of the article. There will be no end date to sharing of data. Any persons may request data. They may use the data for systematic reviews, etc.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 29/03/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information