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临床试验/NCT03560206
NCT03560206已完成不适用

Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads

Misook L. Chung1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2015年3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
已完成
发起方
入组人数
316
试验地点
1
主要终点
Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels

研究概览

简要总结

The Family Sodium Watcher program in this study is designed to improve adherence to a sodium restricted diet in patients with HF using strategies that educate both patients and family caregivers about sodium monitoring and that stress a gradual progressive adaptation to low sodium food for both patients and family caregivers.

详细描述

Heart failure (HF) emerged as a significant public health threat in the 1990s and has now reached epidemic proportions. Despite advances in the medical treatment of HF, patients with HF face frequent hospitalizations for acute exacerbations. Inadequate self-care strategies, in particular non-adherence to a sodium restricted diet (SRD), is a main cause of these rehospitalizations. Prior interventions to increase adherence have focused on increasing knowledge about restricting sodium in the diet have met with limited success. Unaddressed by these interventions are the major barriers of measuring and tracking daily sodium intake, family members who continue to eat high sodium diets, and a preference for salty foods-particularly in the elderly who have a decreased sense of taste. It is possible to retrain the taste buds to enjoy low salt foods by gradually reducing the amount of sodium in foods over the course of 16 weeks. This retraining works best with direct involvement and support from family members. The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a SRD by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods.

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
Single (Participant)

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Eligible patients will:
  • •have diagnosis of chronic HF with either preserved or reduced ejection fraction
  • •have a dedicated primary family caregiver
  • •be able to speak and write English
  • •Eligible caregivers will:
  • •be a primary caregiver identified by the patient
  • •the spouse, committed partner, or family member living with the HF patient
  • •be able to speak and understand English
  • •have no obvious major clinical cognitive impairment that would impair ability to give informed consent
  • •have no major co-morbidities (i.e. HF, cancer, renal/liver failure, or uncontrolled diabetes as determined by self-report).

排除标准

  • •Patients will be excluded if they have:
  • •major clinical cognitive impairment (i.e., dementia, Alzheimer disease, and severe stroke)
  • •a co-existing terminal illness (e.g., cancer)
  • •a referral for heart transplantation
  • •a dietary prescription that prevents following a 2-3 gram sodium diet (e.g., clinician does not support use of a SRD).
  • •no dedicated caregivers

研究组 & 干预措施

Family SWaP intervention

Experimental

an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.

干预措施: Family SWaP intervention (Behavioral)

Usual Care

Active Comparator

The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.

干预措施: usual care (Behavioral)

结局指标

主要结局

Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels

时间窗: Up to 1 year

Baseline: Patient adherence to a sodium-restricted diet was assessed using 24-hour urinary sodium excretion at 3-time points at baseline, 4-months, and 12 months.

次要结局

  • All Cause Hospitalization/Mortality(12 months)

研究者

发起方
Misook L. Chung
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Misook L. Chung

Principal Investigator

University of Kentucky

研究点 (1)

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