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.: PACTR202308749877436 Date of Approval: 24/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of validated infographics on self-management among patients with type II diabetes mellitus for prevention of chronic kidney disease in rural Kenya.
Official scientific title Impact of validated infographics on self-management among patients with type II diabetes mellitus for prevention of chronic kidney disease in rural Kenya.
Brief summary describing the background and objectives of the trial Approximately 1·2 million people died from CKD in 2017 while the global CKD mortality rate increased by 41·5% between 1990 and 2017 with regions within the low socioeconomic index such as sub-Saharan Africa where Kenya is located, accounting for most of the CKD disease burden. The health effects and complications that result from CKD greatly increase the risk for adverse health outcomes, such as: end-stage renal disease (ESRD), cardiovascular disease, and high morbidity and mortality (Vos et al, 2020, P.721). Diabetes mellitus is one of the leading causes of CKD in low-income countries and accounts for 44% percent of all new cases (Ghaderian & Beladi, 2014, p.29; National Kidney Foundation, 2016, online). Unfortunately, CKD is usually asymptomatic until the disease progresses to advanced stages (Fink et al., 2012, p. ES-1). Poor control of diabetes results in a higher rate of CKD progression towards ESRD (Go et al., 2018, p.10 &11). The progression of early CKD is caused by kidney injury events resulting in glomerulosclerosis and tubulointerstitial injury mainly resulting from the effects of uncontrolled hypertension and diabetes. Out of all the patients with CKD in Kenya, about 10,000 have ESRD and require dialysis, yet only 10% are able to access the services. This is because Kenya has less than 100 working dialysis machines countrywide which is significantly low for a country with a population of 47 million (The Kenya Renal Association, 2019, online). Considering the inadequacy of renal replacement therapy services in Kenya, self-management among patients with type II diabetes mellitus is critical to prevent CKD development, slowing disease progression, and preventing complications. The current study aims to establish the impact of the validated self-management infographics for prevention of chronic kidney disease in patients with type II diabetes mellitus in rural Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2023
Actual trial start date 08/08/2023
Anticipated date of last follow up 28/12/2023
Actual Last follow-up date 03/11/2023
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants)
Recruitment status 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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine care monthly one month The group will receive routine care offered at the facility which includes review by a clinician, blood pressure monitoring and capillary blood glucose monitoring 160 Uncontrolled
Experimental Group medication storage bag a booklet and phone call follow up One medication storage bag One booklet one phone call followup one month The current study’s intervention will be an infographic booklet, a medication storage bag printed with infographics on self-management of diabetes mellitus to for the patient to take home as well as a follow-up phone call. In addition to receiving the routine care provided at the facility which includes review by a clinician, blood pressure, and capillary blood glucose monitoring, each participant at the intervention site will be presented with a booklet and a medication storage bag with the infographic printed on them to take home. A discussion session with the participants will be held to clarify and respond to any questions the participant may have on the infographics. During the discussion, the participants will also be advised to read and/ or view the images on the infographic at home so at to enhance knowledge of chronic kidney disease, the relationship between type II diabetes mellitus and chronic kidney disease as well as how to enhance self-management activities. Participants will also be advised to discuss the infographic with the individuals they live with where possible. This will likely allow the family and/or friends to support the participant in self-management. The participants will be given instructions to place the infographic where they can view it as often as possible to remind themselves of the information shared. A follow-up phone call interview will be made with each of the participants after two weeks following the issuance of the infographics. 160
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting patients aged 18 years and above diagnosed with diabetes mellitus type II Patients diagnosed with visual impairments Patients diagnosed with impaired memory Patients attending the outpatient clinic who upon clinical review are getting admitted to receive inpatient care on the recruitment date. 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) 130 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 21/11/2022 Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 339 Bloemfontein 9300 South Africa
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 14/11/2022 Mount Kenya University ISREC
Ethics Committee Address
Street address City Postal code Country
PO BOX 342 THIKA 01000 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome chronic kidney disease knowledge Before the intervention and after the intervention
Primary Outcome Blood pressure before and after the intervention
Secondary Outcome capillary blood glucose level Before and after the intervention
Secondary Outcome Medication Adherence level Before and after the intervention
Secondary Outcome diet adherence level Before and after the intervention
Secondary Outcome self efficacy level before and after the intervention
Secondary Outcome social support level before and after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bellevue Health Centre Nyeri Nyeri Kenya
Ihururu Health Centre Nyeri Nyeri Kenya
Kiganjo Health Centre Nyeri Nyeri Kenya
Edarasha Health Centres Nyeri Nyeri Kenya
Gichiche Health Centre Nyeri Nyeri Kenya
Kamoko Health Centre Nyeri Nyeri Kenya
Mweiga Health Centre Nyeri Nyeri Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Pauline Muthoni Maina 10544 Nairobi 00200 Kenya
DR EDWARD KING SCHOLARSHIP 205 Nelson Mandela Dr, Park West Bloemfontein 9301 South Africa
Faculty of Health Sciences Bursary 205 Nelson Mandela Dr, Park West Bloemfontein 9301 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor none not applicable not applicable Kenya none
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pauline Maina muthonipauline015@gmail.com +254726796761 10544
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya PhD student University of the Free state South Africa
Role Name Email Phone Street address
Public Enquiries Pauline Maina muthonipauline015@gmail.com +254726796761 10544
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya PhD student University of the Free State South Africa
Role Name Email Phone Street address
Scientific Enquiries Pauline Maina muthonipauline015@gmail.com +254726796761 10544
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya PhD student University of the Free State South Africa.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The researcher will make available de-identified individual participant’s data- yes Data that will be shared -De-identified individual participant data reported in the article to be published Any other related documents that will be made available?- Study protocol The period when data will be available (start and end date) -November 2024 to November 2026 Data access criteria- Data will be shared with researchers who will avail relevant and sound research proposals to enable the researcher to achieve the aims of the proposal. How will data be made available- Relevant proposals should be directed to muthonipauline015@gmail.com The interested researcher will be requested to sign a data access agreement upon which the de-identified data will be shared. The research protocol will be made available at https://ufs.figshare.com Study Protocol From November 2024 to November 2026 The proposal should be directed to muthonipauline023@gmail.com To gain access, data requestors will need to sign a data access agreement. Data will be shared directly with the requestor.
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