search
Back to results

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

Primary Purpose

Hypertension, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BP education and BP self-regulation
Supportive Educative Nursing Intervention
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Blood Pressure, End Stage Renal Disease, Hemodialysis, Interdialytic Weight Gain, Self-Regulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Davita Detroit Kresge Hemodialysis Unit
  • William Beaumont Hemodialysis Units

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BP Education and Self Regulation of BP

Usual Care

Arm Description

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.

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. .

Outcomes

Primary Outcome Measures

Blood Pressure
Average BPs were calculated from the hemodialysis flow sheets. Pre hemodialysis BPs were averaged to determine BP at baseline, 12 weeks and 16 weeks

Secondary Outcome Measures

Interdialytic Weight gain (IDWG) - Weight gain in kg between hemodialysis treatments
IDWGs were calcuated by subtracting the patient's weight after their last HD treatment from weight before the next HD treatment. Three IDWGs were averaged in order to determine mean weekly IDWG

Full Information

First Posted
January 19, 2010
Last Updated
November 1, 2017
Sponsor
Wayne State University
search

1. Study Identification

Unique Protocol Identification Number
NCT01052220
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hemodialysis
Keywords
Hypertension, Blood Pressure, End Stage Renal Disease, Hemodialysis, Interdialytic Weight Gain, Self-Regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomized to intervention group of standard care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BP Education and Self Regulation of BP
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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. .
Intervention Type
Behavioral
Intervention Name(s)
BP education and BP self-regulation
Other Intervention Name(s)
Home Blood Pressure Monitoring, Goal Setting, Reinforcement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Educative Nursing Intervention
Other Intervention Name(s)
Self-regulation
Intervention Description
BP Education, BP, salt and fluid monitoring, BP goal-setting, and reinforcement
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Average BPs were calculated from the hemodialysis flow sheets. Pre hemodialysis BPs were averaged to determine BP at baseline, 12 weeks and 16 weeks
Time Frame
12 weeks and 16 weeks post intervention
Secondary Outcome Measure Information:
Title
Interdialytic Weight gain (IDWG) - Weight gain in kg between hemodialysis treatments
Description
IDWGs were calcuated by subtracting the patient's weight after their last HD treatment from weight before the next HD treatment. Three IDWGs were averaged in order to determine mean weekly IDWG
Time Frame
12 weeks and 16 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years average 4 week pre HD systolic BP > 150 mmHg or diastolic BP > 90 mmHg read and speak English. Exclusion Criteria: on HD < 6 months history of illicit drug use current major depression lack of orientation to person, time or place or score or < 80 on the Modified Mini Mental Status Screen major health problems ie. terminal cancer or HIV missed > 2 HD treatments over 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zorica Kauric-Klein, MSN
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davita Detroit Kresge Hemodialysis Unit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hemodialysis Units
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs