Clinical trial NCT01052220: Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention
Official title: Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hemodialysis
Keywords: Hypertension
Blood Pressure
End Stage Renal Disease
Hemodialysis
Interdialytic Weight Gain
Self-Regulation
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to intervention group of standard care.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. \> 18 years
2. average 4 week pre HD systolic BP \> 150 mmHg or diastolic BP \> 90 mmHg
3. read and speak English.

Exclusion Criteria:

1. on HD \< 6 months
2. history of illicit drug use
3. current major depression
4. lack of orientation to person, time or place or score or \< 80 on the Modified Mini Mental Status Screen
5. major health problems ie. terminal cancer or HIV
6. missed \> 2 HD treatments over 4 weeks.

Primary outcomes:
measure: Blood Pressure
timeFrame: 12 weeks and 16 weeks post intervention
Secondary outcomes:
measure: Interdialytic Weight gain (IDWG) - Weight gain in kg between hemodialysis treatments
timeFrame: 12 weeks and 16 weeks post intervention
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Davita Detroit Kresge Hemodialysis Unit
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hemodialysis Units
state: Michigan
Study officials:
affiliation: Wayne State University
name: Zorica Kauric-Klein, MSN
role: PRINCIPAL_INVESTIGATOR
References: