Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention
NCT ID: NCT01052220
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
118 participants
INTERVENTIONAL
2009-06-30
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BP Education and Self Regulation of BP
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 received a BP educational session at baseline and were 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 made weekly visits 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.
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.
Supportive Educative Nursing Intervention
BP Education, BP, salt and fluid monitoring, BP goal-setting, and reinforcement
Usual Care
Participants in the usual care group did not receive the intervention but continued to receive their standard care in the hemodialysis unit which involved follow-up by the medical provider and BP medication adjustments as needed. .
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Supportive Educative Nursing Intervention
BP Education, BP, salt and fluid monitoring, BP goal-setting, and reinforcement
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. average 4 week pre HD systolic BP \> 150 mmHg or diastolic BP \> 90 mmHg
3. read and speak English.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wayne State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zorica Kauric-Klein
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zorica Kauric-Klein, MSN
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Davita Detroit Kresge Hemodialysis Unit
Detroit, Michigan, United States
William Beaumont Hemodialysis Units
Royal Oak, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIC# 2009-94
Identifier Type: OTHER
Identifier Source: secondary_id
020-2009
Identifier Type: OTHER
Identifier Source: secondary_id
0904007039
Identifier Type: -
Identifier Source: org_study_id