跳至主要内容
临床试验/NCT07184541
NCT07184541招募中不适用

The Effect of a Nurse-led Daily Weight Monitoring Intervention (Wake and Weigh) on Heart Failure Quality of Life and Self-care

Lee Anne Siegmund1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
Project Feasibility-fidelity

研究概览

简要总结

Ongoing self-care for heart failure is essential to avoid complications and hospitalization. Supportive strategies are needed; however, patients with heart failure may find many interventions complicated and overwhelming. The purpose of this pilot study is to implement a simple weight tracking tool (Wake and Weigh) to affect self-care and quality of life in a population of older adults with heart failure. This will be a randomized controlled pilot trial to test the methods to be used in a larger randomized controlled trial. The Self-care in Heart Failure Index and Kansas City Cardiomyopathy Questionnaire surveys will be given at admission and four weeks after discharge. The Wake and Weigh tool is designed to help patients track weight in the hospital and following discharge. Feasibility endpoints will be summarized descriptively.

详细描述

Research question: Are the methods used in a pilot study that is designed to implement a nurse-led daily weight monitoring intervention, appropriate for a larger study to be conducted later, which will test the intervention's effect on self-care and quality of life among older adults with heart failure, compared to those who receive routine care? It may be unrealistic to expect patients to have the agency to perform adequate self-care when they are living with activity-limiting symptoms, and perceive that heart failure (HF) self-care instructions are complicated. Given that HF symptoms interfere with the ability to perform self-care, it is vital to concurrently address symptoms and self-care, while also attempting to reduce information overload. Therefore, the purpose of this pilot study is to implement a simple weight tracking tool to affect HF self-care and HF quality of life (using a measure that focuses on symptoms and quality of life) in a population of adults age 55 years and older who have HF, and test the methods to be used in a larger study.

  1. The primary (exploratory) aims of this pilot study are to test methods to be used in a future randomized controlled trial:

  2. Determine intervention fidelity by 1) examining unintended variations in intervention implementation by nurse investigators, and 2) evaluating use (versus no use) of the Wake and Weigh tool by participants.

  3. Determine the feasibility of recruitment by assessing how long it takes to recruit 10% of the anticipated larger study sample size.

  4. Determine the feasibility of randomization and retention for each group.

  5. Test the use and appropriateness of the SCHFI and KCCQ in a population of recently discharged adults aged 55 years and older who have HF who had been admitted to a small regional hospital.

a. Test the appropriateness of the chosen measures by i. Determining percentage of completed SCHFI and KCCQ 2. The secondary aim for this study is to test participants' HF self-care and quality of life i. Reporting test scores for the SCHFI and KCCQ (descriptive) ii. Reporting results of additional questions on confidence, belief, and likelihood of use for Wake and Weigh tool (see variable list) iii. Reporting change in test scores if sample size allows. The setting for this study is a 126-bed regional hospital (Cleveland Clinic, Avon Hospital) in Northeast, Ohio. The hospital inpatient areas include adult medical-surgical units and a 12-bed medical intensive care unit. All inpatient areas in the hospital care for patients with HF. Participants for this study will be selected from a population of adult inpatients at the study site who have a new or existing diagnosis of HF.

The intervention for this study will be the introduction and implementation of the Wake and Weigh tool, which will be provided on hospital admission to patients with HF who are randomized to the intervention group. Currently, usual care education for weight and fluid management is delivered utilizing a HF handbook. Although the handbook is available, patient use of the weight record in the handbook is inconsistent. The handbook is given only on initial HF admission, whereas the Wake and Weigh tool is designed as an additional visual management tool, to remind patients to weigh upon waking and to monitor for weight changes. It is designed for any and all admissions for patients with HF. Further, the Wake and Weigh tool is designed to help patients learn to recognize weight changes through daily weighing, using nurse-led role modeling while they are hospitalized and for easy use at home after discharge.

研究设计

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

入排标准

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

入选标准

  • •Adults (55 years or older)
  • •New or existing diagnosis of HF (regardless of type or length of time since diagnosis).
  • •Being treated for HF signs and/or symptoms during the current hospitalization (any of the following: IV diuretic, fluid restriction, low sodium diet).
  • •Must be able to read and communicate in English.
  • •Must be able to stand and weigh independently.
  • •Must have a scale at home, or ability to obtain one for the study.

排除标准

  • •Documented diagnosis of cognitive impairment.
  • •A Charlson Comorbidity Index (CCI) of >
  • •This was chosen to exclude patients more likely to have hospital stays longer than a week. A CCI of >3 was based on research showing a relationship to mortality (Imam et al., 2020), a CCI of ≥ 6 with a 2.8-times higher mortality (Yilmaz & Omurlu, 2019), and likelihood of longer hospital length of stay for patients with HF if CCI >2 (Foraker et al., 2014).

研究组 & 干预措施

Wake and Weigh Intervention

Active Comparator

The Wake and Weigh weight log in addition to usual care

干预措施: Wake and Weigh (Behavioral)

Control

Active Comparator

The heart failure handbook (routinely given for first heart failure admission), and heart failure education per usual care

干预措施: Usual care (Behavioral)

结局指标

主要结局

Project Feasibility-fidelity

时间窗: From enrollment to the end of treatment at 4 weeks post-discharge

Determine intervention fidelity by examining unintended variations in intervention implementation by nurse investigators

Project feasibility-use of tool

时间窗: From enrollment to the end of treatment at 4 weeks post-discharge

Evaluate use (versus no use) of the Wake and Weigh tool by participants.

Project feasibility-recruitment

时间窗: From enrollment to the end of treatment at 4 weeks post-discharge

Assess how long it takes to recruit 10% of the anticipated larger sample size

Project feasibility-randomization

时间窗: From enrollment to the end of treatment at 4 weeks post-discharge

Assess retention in each randomized group

Project feasibility-appropriateness of SCHFI

时间窗: From enrollment to the end of treatment at 4 weeks post-discharge

Determine percentage of completed SCHFIs

Project feasibility-appropriateness of KCCQ

时间窗: From enrollment to the end of treatment at 4 weeks post-discharge

Determine percentage of completed KCCQs

次要结局

  • Heart Failure Quality of Life(From enrollment to the end of treatment at 4 weeks post-discharge)
  • Heart Failure Self-care(From enrollment to the end of treatment at 4 weeks post-discharge)
  • Heart Failure Quality of Life(From enrollment to the end of treatment at 4 weeks post-discharge)
  • Heart Failure Self-care(From enrollment to the end of treatment at 4 weeks post-discharge)

研究者

发起方
Lee Anne Siegmund
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lee Anne Siegmund

Senior Nurse Scientist

The Cleveland Clinic

研究点 (1)

Loading locations...

相似试验

A Nurse-Led Weight Monitoring Intervention For Heart... | 临床试验