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.: PACTR202001916873358 Date of Approval: 14/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of nurse-led lifestyle choice and coaching intervention on systolic blood pressure among Type 2 diabetes patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster randomized trial
Official scientific title Effect of nurse-led lifestyle choice and coaching intervention on systolic blood pressure among Type 2 diabetes patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster randomized trial
Brief summary describing the background and objectives of the trial More than 50% of patients with type 2 diabetes have hypertension. Diabetic patients with elevated systolic blood pressure experience higher all-cause mortality and cardiovascular events compared with normotensive diabetic individuals hence escalating resource utilization and cost of care. The aim of this study is to determine the effects of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Not applicable
Disease(s) or condition(s) being studied Cardiology,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Effects of a nurse-led life style choice and coaching intervention on systolic blood pressure among patients with type 2 diabetes
Anticipated trial start date 06/07/2020
Actual trial start date 06/07/2020
Anticipated date of last follow up 06/07/2021
Actual Last follow-up date 06/07/2021
Anticipated target sample size (number of participants) 384
Actual target sample size (number of participants) 384
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nurse led life style choice and coaching intervention 12 months The purpose of this trial is to evaluate the effects of a nurse-led lifestyle change education, management, and coaching intervention on systolic blood pressure among patients with type 2 diabetes with a high ASCVD risk score of at least 7.5% as determined by the Pooled Cohort Risk Equations. The intervention will be targeted at both cluster (group) and individual levels. The clusters will be allocated in a 1:1 ratio between intervention and usual care arms. Our intervention is based on Wagner’s Chronic Care Model (CCM) . Wagner’s Chronic Care Model is the best-evidenced strategy to improve diabetes outcomes in the primary care setting. The CCM gives a conceptual framework for reorganizing care from the acute reactive system to a population-based proactively planned care of patients with chronic illnesses such as diabetes, hypertension, and ASCVD.Two nurses from each facility will be recruited and trained for one day at the study head office in Mengo Hospital by an independent trainer. The training will aim to enhance capacity of the nurses to screen and manage hypertension and ASCVD. They will be trained on ASCVD risk factor assessment with the Pooled Cohort Risk Equations, initiation of treatment for hypertension and ASCVD, when and where to refer, and principles of health promotion and behavioral change.The second component of the intervention will be the coaching support where individual participants in the intervention group will be given support at home. The study nurses will make individualized telephone calls, send text messages, and operate a -24-hour mobile telephone service to answer study participants’ questions and concerns. The phone calls will be structured along the health education topics provided at the health facility 192
Control Group Usual care 12 months The control group of the study will be comprised of the usual care that is the doctor or clinical officer-led at health centers IV and higher where either patients are referred by nurses or refer themselves with symptoms of ASCVD. In the usual care, patients with diabetes are not subjected to ASCVD risk quantification. Nurses give general health education on diabetes self-care practice which is not structured along with primary hypertension, and ASCVD prevention and management. Health education does not build a nurse-patient relationship with a well-educated motivated patient at the center. All patients are given the same management package irrespective of their risk factor profile. Management of hypertension and ASCVD in the health facilities in Uganda is not protocol-based as every facility manages diabetes and hypertension differently. Apart from the general Information Education Communication materials at the clinics, patients are not given information leaflets and are not followed with phone calls, text messages and neither can they call the health workers any time of the day. Patients are followed only in the clinics when they are given review appointments by the doctors or clinical officers. Nurses in these facilities have varied training and skill in diabetes management. 192 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult men and women aged 40-79 years with a high ASCVD risk score of at least 7.5% as calculated with a Pooled Cohort Risk Equations. 2. Willing to provide informed consent. 3. Asymptomatic for ASCVD (those without a history of non-fatal myocardial infarction, stroke, heart failure, percutaneous coronary intervention, coronary artery bypass surgery or current atrial fibrillation). 1. Those with symptomatic ASCVD (those with history of non-fatal myocardial infarction, stroke, heart failure, percutaneous coronary intervention, coronary artery bypass surgery or current atrial fibrillation, chronic renal failure) 2. Patients without all variables to calculate the pooled cohort risk score and baseline data. 4. Pregnant women 5. Very ill patients 6. Patients who don’t usually keep appointments that is, those who have attended clinics only once per year. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 79 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 12/12/2019 Mengo Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Sir Albert Cook Road,Mengo Kampala 00256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the trial will be the mean difference in change in systolic blood pressure between baseline, and after 6 and 12 months between intervention and usual care groups at individual and cluster levels. 6 months and 12 months
Secondary Outcome i) absolute difference and relative change in the predicted 10-year ASCVD risk between the intervention and usual care groups at individual and cluster levels after 6 and 12 months. ii) absolute changes in total cholesterol, low-density lipoprotein cholesterol, glycated hemoglobin, body mass index between intervention and usual care groups at individual and cluster levels after 6 and 12 months. iii) differences between groups in the change in proportion of patients reaching treatment goals for systolic blood pressure, total cholesterol, LDL cholesterol glycated hemoglobin, body mass index at individual and cluster levels after 6 and 12 months 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Entebbe Grade B Hospital Entebe main road Entebbe 00256 Uganda
Wakiso Health Center Hoima road Wakiso Uganda
Kasangati Health Center IV Gayaza -Kampala Road Kasangati Uganda
Kawolo Hospital Kampala-Jinja Road Lugazi Uganda
Mityana Hospital Mityana Road Kampala Uganda
Mengo Hospital Sir Albert Cook Road Kampala 00256 Uganda
Namungoona Orthodox Hospital Namungoona Road Kampala 00256 Uganda
Mukono Church of Uganda Hospital Jinja Road Mukono Municipality 00256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Lumu William Namirembe Road Kampala 00256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor William Lumu Namirembe Kampala 00256 Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
Robert Basemberya Jinja Road Lugazi 00256 Uganda
Muwanga Moses Entebbe Main Road Entebbe 00256 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator William Lumu dhabaguma@gmail.com +256772591911 Namirembe Road
City Postal code Country Position/Affiliation
Kampala 00256 Uganda PhD student Texila American University
Role Name Email Phone Street address
Public Enquiries William Lumu dhabaguma@gmail.com +256772591911 Namirembe Road
City Postal code Country Position/Affiliation
Kampala 00256 Uganda PhD student Texila American University
Role Name Email Phone Street address
Scientific Enquiries William Lumu dhabaguma@gmail.com +256772591911 Namirembe Road
City Postal code Country Position/Affiliation
Kampala 00256 Uganda PhD student Texila American University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As a way of monitoring the integrity and progress of the trial , data will be shared with the ethics committee as outlined in the trial protocol. Participants data will also be shared with health care workers in the study health facility if non sharing of such data puts the participants health/life at risk. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD and additional documents will be available at beginning of trial,4 months,8 months and at 12 months of the trial. Access to participants data will be restricted to health care workers in the study facilities and Ethics committee. Access plan by the Ethics committee will be well stipulated in the protocol. Access to health workers will be sanctioned by the Principal Investigator upon receiving a written request. The Ethics committee will be notified about the granted access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Pending 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