Home monitoring and self-management of blood pressure in chronic kidney disease

Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: Recruitment •Potentially eligible participants will be identified using medical records (Vital Data renal system) and nephrology outpatient clinic lists. Potential participants will be posted a cover letter and PIS detailing the study. They will be advised to either contact the research team or be contacted 2 days after receipt of the information to assess interest. •If interest is expressed an eligibility assessment and potential baseline visit will be arranged. In line with PPIE group feedback, the research team will endeavour to align this with existing outpatient appointments to minimise travel and disruption. Eligibility assessment •To establish if standardised blood pressure is over the target – which although recommended, is not routinely measured in outpatient clinics, potential participants will be asked to verbally consent to a standardised blood pressure reading. •Standardised blood pressure will be taken in line with European Society of Cardiology (ESC) guidelines (>5 minutes of rest, caffeine, exercise and smoking avoided 30 minutes prior to measurement and an average of 3 readings taken.) •If standardised BP is over the target (120mmHg or 130mmHg systolic) for higher‐risk or diabetic participants they will be invited to take part. Informed written consent will then be taken in line with GCP guidance. Randomisation •Participants will be randomised using web‐based software provided by Debry CTSU to either the usual care or self‐management (intervention) arm in a 1:1 distribution. Self‐monitoring arm Baseline visit: Demographic data recorded CONDITION: Renal and urogenital ; Urological and Genital Diseases PRIMARY OUTCOME: ; Feasibility outcomes:; Adherence to the intervention will be measured at 6 months and 12 months using patient/study medical notes:; 1. Number of escalations of treatment (dose increase or additional agent) in 12 months; 2. The proportion of participants who have any escalation in their antihypertensive therapy; 3. Number of home blood pressure readings taken by participants in the intervention arm; 4. Study visit completion rates; 5. Response rates to the Revised Illness Perception Questionnaire (IPQ‐R); 6. Proportion of eligible participants willing to be randomised – measured using screening log; SECONDARY OUTCOME: ; Clinical outcomes measured using patient/study medical notes:; 1. Change in standardised office systolic BP between baseline, 6 and 12 months; 2. Proportion of participants who achieve KIDGO systolic BP target <120mmHg; 3. Change in IPQ‐R scores over 12 months in participants (measured at baseline, 6 months and 12 months); ; Safety outcomes:; Incidence of adverse events such as symptomatic hypotension, syncope, falls, AKI, electrolyte abnormalities, changes in eGFR or albuminuria – through CRF hospital admissions, self‐reported AEs and blood and urine tests measured at 6 and 12 months.; INCLUSION CRITERIA: 1. Capable of giving informed consent 2. > = 18 years 3. Chronic kidney disease stages 1‐4 looked after in secondary care nephrology 4. Standardised office systolic BP > 120 mmHg or > 130 mmHg with diabetes
Epistemonikos ID: f86e41f59ae5921641c6e1909d0ecd4213d8a2fa
First added on: Feb 20, 2024