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临床试验/NCT01052220
NCT01052220已完成不适用

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

Wayne State University4 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2009年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
4
主要终点
Blood Pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

BP Education and Self Regulation of BP

Experimental

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.

干预措施: BP education and BP self-regulation (Behavioral)

BP Education and Self Regulation of BP

Experimental

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.

干预措施: Supportive Educative Nursing Intervention (Behavioral)

Usual Care

No Intervention

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. .

结局指标

主要结局

Blood Pressure

时间窗: 12 weeks and 16 weeks post intervention

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

次要结局

  • Interdialytic Weight gain (IDWG) - Weight gain in kg between hemodialysis treatments(12 weeks and 16 weeks post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zorica Kauric-Klein

Assistant Professor

Wayne State University

研究点 (4)

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