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.: PACTR202201708421484 Date of Approval: 11/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diabetic Foot Self Care Programme in Ghana
Official scientific title Family-oriented Diabetic Foot Self-care Programme in Ghana; A Feasibility Randomised Controlled Trial with nested qualitative interviews at the Komfo Anokye Teaching Hospital.
Brief summary describing the background and objectives of the trial Background: The most common and expensive to treat complication of diabetes is diabetic foot ulcer (DFU), and persons with diabetes have about 25% risk of developing foot ulcers and neuropathies in their lifetime. Informal caregivers, herein refers to as family caregivers (persons providing unpaid services at home) can play significant role in patients’ disease management and involving them in self-care interventions could lead to improve diabetic foot outcomes. DFU preventive training and education programmes engaging both persons with diabetes and their family caregivers in the USA, China, Indonesia, and other countries, are known to have resulted in improved foot self-care practices and reduced incidence of foot ulcers. However, it is not known if such family-oriented interventions apply or is feasible in Ghana . Aim: The primary aim of this research is to evaluate the feasibility of conducting a randomised controlled trial to investigate the effectiveness of a hands-on skills training and education on foot self-care programme for persons with diabetes and their family caregivers in Ghana. The research question is ‘can the provision of a family-oriented foot self-care skills training and education intervention improve foot care behaviour, foot care self- efficacy, knowledge of diabetic foot and diabetes distress among persons with diabetes and their caregivers in Ghana?’
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 01/02/2022
Actual trial start date
Anticipated date of last follow up 30/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diabetic Foot Self Care Education and Training Weekly for four weeks Four 50-minutes sessions The intervention is a Foot Selfcare education and training programme. Components of this intervention include (1) Self-management (experiential workshops on foot self-care and education) and (2) Family management (strengthening the family support on problem solving in foot ulcer prevention, establishing family roles and effective involvement in foot ulcer prevention) delivered through face-to-face intensive health education and skills training. Participants in the intervention group will each receive the following: (i) nail clippers for proper cutting of toenails (ii) a plastic handy mirror for inspection of bottom of feet, (iii) a 10g monofilament for checking feet sensations and (iv) bag to contain all equipment. After self-management education, demonstration by the nurse and return demonstration of foot care by patients and caregivers, each participant, assisted by their caregiver will be asked to perform daily foot care at home. Participants in this intervention group will also continue to receive their routine or usual care from the diabetic clinic. Thus, they will continue to access health care services from their healthcare provider as they would usually do. 50
Control Group Routine or usual care at the diabetic clinic four weeks Participants in the control group will continue to receive their routine or usual care from the diabetic clinic staff. They will not be deprived of any service they would usually receive on their visit for their clinic appointment. This may include being assessed or treated by nurses and physicians on their regular appointments visits at the hospital. Thus, the research does not stop them from continuing their everyday treatment as may be indicated to them by their health service provider. 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria for Persons with Diabetes: Adults aged ≥18 years with a confirmed diagnosis of type 1 or 2 diabetes Participants fulfil at least one of the following three criteria for definition of high risk for foot ulcers; (i) medically confirmed diagnosis of neuropathy , (ii) previous/healed diabetic foot ulcer or (iii) foot abnormalities at risk of ulcer in the opinion of the investigator (iv) venous insufficiency (skin colour change or temperature difference) (ADA 2018). Have a family caregiver who live with them and/or assisted them in their day-to-day self-care activities and willing to participate in the study with them. Persons who attended the KATH diabetes review clinic or were admitted to the KATH diabetes unit. Able to provide informed consent to participate in the trial. Inclusion criteria for family caregivers: Persons ≥18 years and living with the individual with diabetes and/or assisted them on daily basis with care activities. Individuals willing to participate in the study and willing to attend appointments with their relative that has diabetes for research related activities Able to provide an informed consent Exclusion criteria for persons with diabetes: People with peripheral vascular disease requiring immediate revascularization. Persons with severe mental illness or cognitive impairment Persons with current foot ulcers. Exclusion criteria for family caregivers: Persons with severe mental illness or cognitive impairment Caregivers under 18 years of age Caregivers who are sick and requiring immediate medical attention 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 22/12/2021 Komfo Anokye Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Kumasi-Ghana Kumasi 1934 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Participants recruitment and retention rate 12 weeks
Secondary Outcome Knowledge on diabetic foot 12 weeks
Secondary Outcome Foot care behaviour 12 weeks
Secondary Outcome Foot self-care efficacy 12 weeks
Secondary Outcome Diabetes Distress 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Komfo Anokye Teaching Hospital Kumasi-Ghana Kumasi 1934 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Joseph Suglo Komfo Anokye - Kumasi Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kings College London Waterloo Road SE1 8WA London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr. Frank B Micah Komfo Anokye - Kumasi Kumasi Ghana
Dr Kirsty Winkley Waterloo Road, SE1 8WA London United Kingdom
Professor Jackie Sturt Waterloo Road, SE1 8WA London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Ngmenesegre Suglo suglojoseph@gmail.com +233242634299 Komfo Anokye - Kumasi
City Postal code Country Position/Affiliation
Kumasi Ghana Kings College London
Role Name Email Phone Street address
Public Enquiries Joseph Ngmenesegre Suglo suglojoseph@gmail.com +233242634299 Komfo Anokye-Kumasi
City Postal code Country Position/Affiliation
Kumasi Ghana Kings College London
Role Name Email Phone Street address
Scientific Enquiries Jackie Sturt jackie.sturt@kcl.ac.uk +447743190301 Waterloo Road SE1 8WA
City Postal code Country Position/Affiliation
London United Kingdom Kings College London
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results that will be reported in this study, after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol Immediately following publication in peer reviewed journal, No end date. Anonymous results of this study will be made publicly available through peer reviewed journals and can be accessed by anyone who wishes to use them.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information