Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention
Recruitment status was: Recruiting
Behavioral: BP education and BP self-regulation
Behavioral: Supportive Educative Nursing Intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention|
- Blood Pressure [ Time Frame: 12 weeks and 16 weeks post intervention ] [ Designated as safety issue: No ]
- Interdialytic Weight gain (IDWG) - Weight gain in kg between hemodialysis treatments [ Time Frame: 12 weeks and 16 weeks post intervention ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||July 2010|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Experimental: BP Education and Self Regulation of BP||
Behavioral: BP education and BP self-regulation
The intervention will consist of 3 phases: 1) BP education sessions, 2) 12 week intervention and 3) 30 day post intervention follow-up period. The participants in the treatment group will be asked to monitor and record home BP daily, 24 hour fluid intake and complete a salt intake check-lists twice weekly for 12 weeks.
The PI will visit weekly with the intervention participants in the HD unit. to 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.
Other Names:Behavioral: Supportive Educative Nursing Intervention
BP Education, BP, salt and fluid monitoring, BP goal-setting, and reinforcement
Other Name: Self-regulation
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) ESSI Social Support Instrument 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052220
|United States, Michigan|
|Davita Detroit Kresge Hemodialysis Unit|
|Detroit, Michigan, United States, 48202|
|William Beaumont Hemodialysis Units|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Zorica Kauric-Klein, MSN||Wayne State University|