Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Wayne State University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT01052220
First received: January 19, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Hypertension
Hemodialysis
Behavioral: BP education and BP self-regulation
Behavioral: Supportive Educative Nursing Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 12 weeks and 16 weeks post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
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)
Arms Assigned Interventions
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:
  • Home Blood Pressure Monitoring
  • Goal Setting
  • Reinforcement
Behavioral: Supportive Educative Nursing Intervention
BP Education, BP, salt and fluid monitoring, BP goal-setting, and reinforcement
Other Name: Self-regulation

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) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052220

Contacts
Contact: Zorica Kauric-Klein, MSN 248-425-1274 ai6191@wayne.edu

Locations
United States, Michigan
Davita Detroit Kresge Hemodialysis Unit Recruiting
Detroit, Michigan, United States, 48202
Contact: Zorica Kauric-Klein, MSN    248-425-1274    ai6191@wayne.edu   
Principal Investigator: Zorica Kauric-Klein, MSN         
William Beaumont Hemodialysis Units Active, not recruiting
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Zorica Kauric-Klein, MSN Wayne State University
  More Information

No publications provided

Responsible Party: Zorica Kauric-Klein, MSN, APRN-BC, Wayne State University
ClinicalTrials.gov Identifier: NCT01052220     History of Changes
Other Study ID Numbers: 0904007039, HIC# 2009-94, 020-2009
Study First Received: January 19, 2010
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wayne State University:
Hypertension
Blood Pressure
End Stage Renal Disease
Hemodialysis
Interdialytic Weight Gain
Self-Regulation

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on July 28, 2014