TY - JOUR
T1 - Effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk
T2 - study protocol for a cluster-randomized trial
AU - Lumu, William
AU - Kibirige, Davis
AU - Wesonga, Ronald
AU - Bahendeka, Silver
N1 - Funding Information:
We acknowledge the support of the 8 study health facilities. Sincere appreciation goes to all study nurses who will contribute to patient recruitment. Furthermore, we thank the peer leaders who will assist the study nurses in the conduction of the study. WL, SB, RW, and DK conceptualized and designed the manuscript and revised and approved its final version. WL is the principal investigator of this trial. RW and SB participated in the development of the intervention and statistical plans. All the authors revised and approved the final version. All the authors declare that they have no competing interests. The study is part of William Lumu?s self-funded PhD with Texila American University located in Georgetown, Guyana. The funding of this study is largely from personal savings and a student loan. These financial resources will cover study nurses? time, phone calls, text messages, 24-h mobile telephone service, proposed transport refund, and dissemination of trial results. Since the trial is self-funded, the principal investigator oversees and pays for the trial. He will oversee data collection and analysis in conjunction with the study coordinator and biostatistician. Data sets in an anonymous form will be availed from the corresponding author upon request. Data will be reported or published in journals and reports anonymously. This study was approved by Mengo Hospital Research Ethics Committee (MHREC) on 12th December 2019. The study number is 100/9-2019. The study is registered with the Uganda National Council of Science and Technology (UNCST) reference number HS/2738. Written informed consent will be sought from the potential participants. The informed consent form will describe the study title and outline the study objectives, procedures, voluntariness, risks, confidentiality, and reimbursement allowance. The consent form is both in English and the local language (Luganda).
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: More than 50% of patients with type 2 diabetes have hypertension in Uganda. 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 effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk. Methods: This is a cluster-randomized study comprising two arms (intervention and non-intervention—control arm) with four clusters per arm with 388 diabetic patients with a high predicted 10-year atherosclerotic cardiovascular risk. The study will be implemented in 8 health facilities in Uganda. The intervention arm will employ a nurse-led lifestyle choice and coaching intervention. Within the intervention, nurses will be trained to provide structured health education, protocol-based hypertension management, and general atherosclerotic cardiovascular risk factor management, 24-h phone calls, and 2-monthly text messaging. The control group will be constituted by the usual care. The primary outcome measure is the mean difference in systolic blood pressure between the intervention and usual care groups after 6 months. The study is designed to have an 80% statistical power to detect an 8.5-mmHg mean reduction in systolic blood pressure from baseline to 6 months. The unit of analysis for the primary outcome is the individual participants. To monitor the effect of within-cluster correlation, generalized estimating equations will be used to assess the changes over time in systolic blood pressure as a continuous variable. Discussion: The data generated from this trial will inform change in the policy of shifting task of screening of hypertension and atherosclerotic cardiovascular disease from doctors to nurses. Trial registration: Pan African Trials Registry PACTR 202001916873358. Registered on 6 October 2019
AB - Background: More than 50% of patients with type 2 diabetes have hypertension in Uganda. 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 effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk. Methods: This is a cluster-randomized study comprising two arms (intervention and non-intervention—control arm) with four clusters per arm with 388 diabetic patients with a high predicted 10-year atherosclerotic cardiovascular risk. The study will be implemented in 8 health facilities in Uganda. The intervention arm will employ a nurse-led lifestyle choice and coaching intervention. Within the intervention, nurses will be trained to provide structured health education, protocol-based hypertension management, and general atherosclerotic cardiovascular risk factor management, 24-h phone calls, and 2-monthly text messaging. The control group will be constituted by the usual care. The primary outcome measure is the mean difference in systolic blood pressure between the intervention and usual care groups after 6 months. The study is designed to have an 80% statistical power to detect an 8.5-mmHg mean reduction in systolic blood pressure from baseline to 6 months. The unit of analysis for the primary outcome is the individual participants. To monitor the effect of within-cluster correlation, generalized estimating equations will be used to assess the changes over time in systolic blood pressure as a continuous variable. Discussion: The data generated from this trial will inform change in the policy of shifting task of screening of hypertension and atherosclerotic cardiovascular disease from doctors to nurses. Trial registration: Pan African Trials Registry PACTR 202001916873358. Registered on 6 October 2019
KW - Atherosclerotic cardiovascular risk
KW - Coaching intervention
KW - Nurse-led lifestyle choice
KW - Randomized controlled trial
KW - Systolic blood pressure
KW - Type 2 diabetes
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UR - http://www.scopus.com/inward/citedby.url?scp=85100968898&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05085-z
DO - 10.1186/s13063-021-05085-z
M3 - Article
C2 - 33573687
AN - SCOPUS:85100968898
VL - 22
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 133
ER -