A Randomized Trial of Home Self-Efficacy Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 415
- 试验地点
- 2
- 主要终点
- Health related quality of life (HRQoL) at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
研究概览
简要总结
The purpose of the study is to determine the effectiveness of a home-delivered variant of the chronic disease self management program in improving health outcomes in patients with chronic conditions.
详细描述
Key reasons for the "quality chasm" between current and ideal chronic illness care are that our health care system is insensitive to patient preference, provider-driven, and disease-focused. By contrast, a common goal among proposed patient-centered care models is to foster continuous healing relationships between patients and the health care system. Such relationships allow patients to receive care over time via a variety of communication media, rather than just via periodic office visits. Home health care can foster such relationships and improve outcomes for patients with a variety of conditions. Home interventions may be particularly useful in caring for the growing number of people with chronic illnesses accompanied by functional limitations that reduce their access to community-based interventions such as group self-care classes. However, trials comparing the effectiveness of the wide array of home care models are limited, and the mechanisms that underlie their effectiveness remain unclear.
This randomized controlled trial (RCT) of 3 groups, comparing the effectiveness and cost-effectiveness of 2 different home-based care models and usual care in improving chronic illness outcomes, will address these research gaps. The primary outcome will be health-related quality of life (HRQoL). We will also explore the mechanisms of effectiveness of home care through its influence on self-efficacy - beliefs patients have about their ability to successfully execute the actions required to achieve valued health outcomes - and adherence. The chronic illnesses targeted will be diabetes mellitus (DM), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), asthma, arthritis, and depression. The home care delivery media in the models will be in-person visits, and standard telephone calls. The study hypotheses are: a) Each of the 3 different home interventions will result in improvements in patient self-efficacy, adherence to care, and HRQoL compared with usual care but will not differ statistically; b) From the payer's perspective, all the interventions will be cost saving compared with usual care, and a standard telephone intervention will be the most cost saving; and c) Self-efficacy will improve temporally before adherence to care and HRQoL.
The research proven framework for improving patient self-efficacy that we will employ in our interventions, the Chronic Disease Self-Management Program (CDSMP), was developed at Stanford University. It was designed to be delivered by trained laypersons to groups of patients in community settings. The CDSMP developers will serve as consultants on our study, assisting us with modifying the program for delivery by trained lay visitors to individual patients in their homes.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receive primary care 1 of 12 UC Davis Primary Care Network (PCN) offices
- •live in a private home
- •age 40 or older
- •able to read and speak english
- •Adequate vision and hearing to read study materials and use a standard telephone
- •have one or more of the following conditions: arthritis, asthma, COPD, CHF, depression, DM
- •suffer functional impairment as manifest by at least one of the following: self-reported impairment in at least 1 basic activity of daily living on Health Assessment Questionnaire (HAQ); or score higher than 3 on the 10-item version of the Center for Epidemiologic Studies Depression Scale (CES-D)
排除标准
- 未提供
结局指标
主要结局
Health related quality of life (HRQoL) at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
次要结局
- self-care self-efficacy at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
