Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome - a Randomized Controlled Trial in Primary Health Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Composite score of changes
研究概览
简要总结
The goal of the research project PROMISE is to translate the person-centred care (PCC) principles into an eHealth (the use of information and communication technologies for health) context. A developed PCC eHealth platform will be used as a tool to identify patients´ resources to enhance coping and living with their illness by means of a dialog and partnership with staff and relatives. The PCC eHealth platform will not replace, but instead be used as add on treatment to usual care (guideline directed care).
详细描述
A pilot study and collaboration between patients, relatives and professionals in the research program has clarified the need to develop a PCC eHealth platform. Previous research has shown that eHealth support, where the users are not involved in the process, has a low impact and has highlighted several limitations with respect to: patients' participation in the design process; its anchorage in the home and local environment and opportunities for communication rather than information. Therefore this study has a participatory design which assumes that all users (patients, relatives and health care professionals) are involved in the study design which facilitates implementation. An end-user perspective as a starting point increases the chances that users adapt a positive attitude towards the new system. Person-centred care combined with an eHealth support along the chain of health care showed a 4-fold chance of improved self-efficacy in combination with return to work or prior activity level after an event of acute coronary syndrome.
The aim of this project is that PCC can be delivered at distance and make health care more effective above and beyond usual care. Inclusion of the principles of PCC in an eHealth support for patients with stress, depression or anxiety will improve return to work rates, reduced relapse, reduce costs and improved self-efficacy.
In the PCC approach, the aims, capabilities and needs of each patient, will be the starting point. Self-care strategies will be reinforced and empowered.
This study is a randomized, open, parallel group intervention study where patients are eligible when they start their sick leave period due to stress, depression or anxiety. They will be asked about participation after being diagnosed and their sick leave has been approved.
Patients will be randomized into either the control or the intervention arm 1:1. The control group will receive usual care. The intervention group will receive usual care plus a PCC intervention through an eHealth platform. Randomization will be done through computer generated lists and stored in sealed envelopes.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women fulfilling criteria for any of the following diagnoses: stress, depression or anxiety and on sick leave since ≤30 days
- •Paid professional work, at least part time, during the last 9 months and willing to participate
排除标准
- •Sick leave >14 days for any of the above mentioned diagnoses during the last 3 months.
- •Severe impairment that prevents patient from using the eHealth support
- •No registered address
- •Not willing to participate
- •Any severe disease with an expected survival <12 months
- •Cognitive impairment
- •Ongoing documented diagnosis of alcohol or drug abuse
- •Other severe disease that can interfere with follow-up or if the intervention is assessed as a burden
- •Patient participating in another conflicting randomized study
结局指标
主要结局
Composite score of changes
时间窗: baseline, 3, 6, 12, 18, 24 months
A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 6 months reduced sick leave and increased general self-efficacy by ≥ 5 units A patient is classified as deteriorated if: at 6 months increased sick leave or (if on full-time sick leave at inclusion reduced general self-efficacy by ≥ 5 units) Those who have neither deteriorated nor improved are considered unchanged
次要结局
- General self-efficacy scale(baseline, 3, 6, 12, 18, 24 months)
- Self-rated burnout syndrome (s-UMS)(baseline, 3, 6, 12, 18, 24 months)
- Health care utilization(3, 6, 12, 18, 24 months)
- Sick leave(baseline, 3, 6, 12, 18, 24 months)
- Health-related quality of Life (EQ-5D)(baseline, 3, 6, 12, 18, 24 months)
- Hospital anxiety and depression scale (HADS)(baseline, 3, 6, 12, 18, 24 months)
- Symptom burden (Shirom-Melamed Burnout Measure)(baseline, 3, 6, 12, 18, 24 months)
- Perceived stress scale (PSS)(baseline, 3, 6, 12, 18, 24 months)
- Incremental cost-utility ratios(3, 6, 12, 18, 24 months)
- Multidimensional fatigue symptom inventory (MFI-20)(3, 6, 12, 18, 24 months)
- Sheehan disability scale (SDS)(3, 6, 12, 18, 24 months)
- Self-efficacy (self-care)(3, 6, 12, 18, 24 months)