Hypertension Clinical Trial
Official title:
Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention
The major purpose of this quantitative study is to determine if a 3 month supportive educative nursing intervention incorporating Blood Pressure (BP) education and BP, salt and fluid monitoring, in addition to goal setting and reinforcement will improve BP control in a chronic end-stage renal disease population.
120 Participants will be recruited for the study. The participants will be randomized to
either an intervention or control group. Randomization will occur according to the
Hemodialysis (HD)unit the participant dialyzes at. The intervention will consist of 3 phases:
1) education sessions, 2) 12 week intervention and 3) 30 day post intervention follow-up
period. The intervention group will receive two 15 minute individual education sessions
conducted by the research coordinator in the HD unit.
The objectives of session 1 are: 1) to explain the underlying pathophysiology and associated
risks of high BP in HD, 2) to identify the goals that can improve BP control and 3) to
describe the role of self-regulation in changing behavior related to BP control. The
objectives of Session 2 include: to provide and demonstrate correct participant use of home
BP monitors, correct recording of home BPs, 24 hr fluid recall and salt intake checklists.
The participants will also receive educational pamphlets on methods to improve salt and fluid
restrictions.
The participants in the treatment group will be asked to monitor and record their home BP,
salt and fluid intake weekly for 12 weeks. The research coordinator will have weekly 10 to 15
minute visits with the intervention participants in the HD unit. The PI will review BP and
fluid logs and salt check lists with the participant to determine if predetermined goals for
BP control were attained. When goals related to BP control are met, positive verbal
reinforcement will be given to the participant. When goals related to BP control are not met,
further exploration and problem solving will be done.
The control group will receive standard care which involves BP monitoring and medication
adjustment by health care providers on a weekly basis in the HD unit as needed. At the end of
the study, both intervention and control groups will receive a home BP monitor as
compensation for participation.
The baseline surveys that will be administered at initiation of the study include: 1)
Modified Mini Mental State Exam (3MS) to measure global cognitive function, 2) Patient Health
Questionnaire (PHQ-9) to screen and measure for depression, 3) ENRICH Social Support
Instrument (ESSI) to measure the participant's level of social support, 4) BP Control in HD
Knowledge Scale to measure the participant's comprehension of behaviors necessary for BP
control in HD and the 5) BP Control in HD Self-efficacy Scale will be used to measure self
confidence in their ability to control BP.
BP Control self-regulation measures will also be monitored and collected throughout the 12
weeks. BP control self-monitoring will be measured as adherence to recommended guidelines for
monitoring in the study. To measure BP control self-evaluation and self-reinforcement,
specific questions will be asked at the end of each BP and fluid log and salt check list to
determine if goals were met or not met and if appropriate self-reinforcement was given.
Pre HD BPs and interdialytic weight gain (IDWG) will be collected weekly in both groups over
12 weeks. After 12 weeks the BP Control Knowledge Test, BP Control Self-Efficacy Scale, PHQ-9
and Morisky scales will be administered to both the intervention and control groups. At 30
days post intervention, the research coordinator will again collect average monthly BP and
fluid gains.
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