Renal and urogenital Urological and Genital Diseases
Conditions
Interventions
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
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Evidence of postural hypotension defined as standing BP 20mmHg) or patient reported symptoms 2. Currently taking > = 4 antihypertensive medications – due to limited scope to up titrate medication. 3. Memory impairment or dementia – such that would prevent the ability to self- monitor and manage medication safely. 4. Pregnancy or breastfeeding or intending pregnancy in trial period – due to different BP targets and medication used in hypertension during pregnancy and limitations on drugs used. 5. Estimated date of requiring dialysis (EDD) within the next 6 months – this is due to the increased risk of side effects and electrolyte abnormalities in titrating medication in this group and the likelihood of completing the 12 month follow up period (most anti-hypertensives are stopped once participants commence dialysis). 6. Renal transplant recipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Contacts
Public ContactBethany Lucas
Outcome results
None listed