Meals MATTER: A Randomized Controlled Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
研究概览
简要总结
The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.
详细描述
The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.
The Investigators propose a research study with four Specific Aims:
Specific Aim 1: To determine if MTM provided post hospitalization for 4 weeks to patients with one or more of seven chronic health conditions will decrease depression/anxiety measured by the Hospital Anxiety and Depression Scale (HADS) at 60 days in comparison to meals provided for 2 weeks to members discharged from two hospitals.
Hypothesis 1: Patients receiving meals for 4 weeks will have a clinically significant increase in their HADS score at 60 days compared to those receiving meals for 2 weeks.
Specific Aim 2: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will improve general well-being and functional status measured by Katz's Activities of Daily Living (ADL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older, with no upper age limit
- •Hospitalized at Saint Joseph Hospital or Good Samaritan Medical Center with the anticipation that they will be discharged home
- •Member of a KP health plan
- •Have one or more of the following conditions:
- •Heart failure
- •End-stage renal disease (ESRD)/chronic renal disease
- •Chronic obstructive pulmonary disease (COPD)
- •Diabetes Mellitus
- •Chronic liver disease/cirrhosis
排除标准
- •Patient discharged to a nursing home, an assisted living facility, or another setting where meals are institutionally provided
- •Patient has a health condition which is incompatible with the diet choices offered by Project Angel Heart (PAH - food service vendor)
- •Patient refuses the type of meal best for their medical condition
- •Patient has dementia
- •Patient is pregnant or hospitalized peri-partum
- •Patient is an active participant in a PAH program or another meal program
- •Patient is unable to speak English or Spanish
- •PAH unable to deliver meals due to patient not being in PAH service area
- •Patient was discharged from the hospital within 24 hours of admission
- •Patient whose household member has enrolled in the Meals MATTER study
- •Patient discharged to hospice care
研究组 & 干预措施
Meals - 2 weeks
Receive meal delivery for 2 weeks (1 meal per day for a total of 14 days). The medically tailored meal ordered for each participant will depend on their medical conditions.
干预措施: Medically Tailored Meals (Other)
Meals - 4 weeks
Receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). The medically tailored meal ordered for each participant will depend on their medical conditions.
干预措施: Medically Tailored Meals (Other)
结局指标
主要结局
Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
时间窗: A change in score from baseline to 60 days
Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.
次要结局
- Re-hospitalization and Emergency Department Visits(60 days from hospital discharge)
- Functional Status measured through the Katz Activities of Daily Living Scale(A change in score from baseline to 60 days)