跳至主要内容
临床试验/NCT04416815
NCT04416815招募中不适用

Integrating Health Promotion With and for Older People - eHealth: a Randomised Controlled Trial, in the Context of Good Quality Local Health Care

Göteborg University2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2021年1月25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
220
试验地点
2
主要终点
A composite of changes in general self-efficacy and need for hospital care

研究概览

简要总结

The Integrating Health promotion with and for Older People eHealth (IHOPe) project is expected to contribute vital knowledge on how older peoples capabilities and societal resources can be used in a more efficient way to promote health, self-management and enhance teamwork in partnership.The aim is to describe and evaluate this person-centered e-support intervention that promotes a sustainable partnership between community-dwelling frail older people and health and social care professionals. A digital platform, co-created with users and designed to create inclusion of individuals who today are living in a digital alienation, will be used in the health planning. In IHOPe frail older people will be able to identify their potential health issues but also their resources together with team partners from health- and social care, family or societal representatives. The intervention consists of person-centered phone calls with a health care professional as well as access to a digital platform that is accessible to the old person and invited team-partners. The project includes a randomized controlled trial, a process evaluation and a health economic evaluation. People 75 years or older screened as frail will be included. Also, in the process evaluation team-partners using the digital platform will be included. Specifically, this project is expected to reduce hospitalizations, result in improved or retained self-efficacy whilst being cost effective. Additionally, the project is expected to enhance frail older peoples opportunities to participate as an equal partner in their contacts with health and social services.

详细描述

Background:

Healthcare systems worldwide are not equipped to accommodate for the growing population of older people. In Sweden alone the proportion of people aged 65 years and older is estimated to increase to 23% by 2030. Furthermore, the number of people aged over 80 years in 2017 exceeded 500 000 and is expected to increase by around 50% by 2027. People in this age group often have an increased risk for developing frailty, multi-morbidity and functional impairments. Thus, there is an urgent call for innovative approaches to both promote health and to design a sustainable healthcare system that is accessible, resource effective and enables health in frail older people. Person-centered care (PCC) and digital health services are considered keystones in such a healthcare system redesign, and may enable efficient and resource effective teamwork that strengthens a preventive approach and promotes older people's self-efficacy. Previous and ongoing studies show that PCC can be delivered at a distance, but needs to be further developed from a teamwork aspect. Therefore, the IHOPe project focuses on integrating health promotion with and for frail older people by working as a team via a digital platform. To the best of our knowledge, no previous research has investigated the effectiveness of initiating health planning with and for frail older people through a PCC telephone support and eHealth intervention where patients are able to create a personal team by inviting informal and formal carers from both health and social care services into their health team if needed.

The overall aim is to describe and evaluate a person-centered eHealth intervention that promotes a sustainable partnership between community-dwelling frail older people and health and social care professionals.

Design:

The IHOPe trial is designed as a randomized, controlled, trial with two parallel groups and a primary endpoint 6 month after inclusion. Randomization will be performed through computer generated lists with a 1:1 allocation. In addition, the IHOPe project includes a pilot and feasibility study, a health economic evaluation and a process evaluation. The project is a complex intervention and as such features a multitude of influencing factors. The study design was guided by the revised Medical Research Council's (MRC) framework for complex interventions. The IHOPe project consists of two phases:

研究设计

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

盲法说明

The nature of the intervention means that neither participants nor the health care professionals (HCP) in the IHOPe intervention can be blinded to allocation in the RCT.

入排标准

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

入选标准

  • National registration within the Västra Götalands region (VGR), community dwelling people (men and women) aged 75 and older living in ordinary housing, and screened as frail at a primary care center or the emergency department but not hospitalized.

排除标准

  • In need of palliative care in the final stages of life, no registered address, participating in any other conflicting randomised study, or cognitive dysfunctional (not oriented to time, place and person).

研究组 & 干预措施

Usual care

No Intervention

The participants allocated to the control group received no intervention. However, they could, on their own initiative, approach the usual range of community or health services (e.g., home help services, rehabilitation, or medical care).

eHealth

Experimental

The intervention will be delivered for 6 months on top of usual care.

干预措施: Integrating Health promotion with and for Older People - eHealth (Other)

结局指标

主要结局

A composite of changes in general self-efficacy and need for hospital care

时间窗: Baseline, 3

The primary outcome is a composite of changes in general self-efficacy and need for hospital care for unscheduled reasons. Each participant will be classified as improved, deteriorated or unchanged if at 3 months: * Deteriorated: the participant's self-efficacy has decreased by ≥ 5 units (the minimal change of clinical significance), or the participant has been admitted to hospital for unscheduled reasons two times or more. * Improved: general self-efficacy has increased by ≥ 5 units and the participant has been admitted to hospital no more than once. * Unchanged: Neither deteriorated nor improved. (Questionnaire and medical record)

次要结局

  • Incremental cost-effectiveness Ratio (ICER)(Baseline, 3, 6, 12 months)
  • Hospitalization(Baseline, 3, 6, 12 months)
  • ICEpop CAPability measure for Older people (ICECAP-O)(Baseline, 3, 6, 12 months)
  • Health-related quality of life by EuroQol 5 dimensions health state questionnaire (EQ5D)(Baseline, 3, 6, 12 months)
  • General Self Efficacy(Baseline, 3, 6, 12 months)
  • Change in daily activities based on the ADL-staircase(Baseline, 3, 6, 12 months)
  • Societal costs(Baseline, 3, 6, 12 months)
  • Change in number of fall(Baseline, 3, 6, 12 months)
  • A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons(Baseline, 6, 12 months)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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