跳至主要内容
临床试验/NCT06212687
NCT06212687招募中不适用

Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care

St. Olavs Hospital2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年12月15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
170
试验地点
2
主要终点
Knowledge and treatment preferences

研究概览

简要总结

Community mental health centers (CMHCs) face significant challenges in meeting the needs of individuals with mental health issues. For example, due to high demand, there are long waiting lists and low engagement rates. Innovative interventions are urgently needed to address these challenges to improve patient engagement, coping skills, and overall health outcomes. Educational and self-management interventions have shown promise in enhancing patient activation and treatment satisfaction in other contexts. They may therefore be potential solutions to reduce the identified challenges in the mental health service. To bridge these knowledge and practice gaps, this study aims to evaluate a digital pre-therapy patient education program tailored specifically for adults with mental disorders. This intervention aims to enhance treatment satisfaction, patient activation, knowledge, patient engagement, and overall mental health outcomes.

详细描述

Community mental health centers (CMHCs) play a pivotal role in the provision of comprehensive care and support for individuals with mental health challenges. However, these centers often face formidable obstacles, including surging patient demands, lengthy waiting lists, high dropout rates, and barriers to engagement, stigma, and negative attitudes. Given these challenges, there exists an urgent imperative to develop innovative interventions that can enhance treatment satisfaction, patient activation, knowledge, and patient engagement, and ultimately yield improved mental health outcomes. One promising approach for addressing these challenges lies in the realm of patient engagement and enablement strategies, particularly through the implementation of digital educational interventions.

The investigators hypothesize that utilizing innovative technology to deliver an early digital self-management educational program improves treatment satisfaction, patient activation, knowledge, patient engagement, and overall mental health outcomes without substantially increasing service costs. The impact of utilizing innovative technology to deliver an early digital pre-therapy patient education program through the HelsaMi web patient portal is promising. By leveraging technology, it is possible to reach a wider audience and provide accessible and convenient information, with the same standard to all patients. This approach has the potential to improve patient outcomes, increase treatment adherence, and reduce the burden on healthcare resources. By demonstrating the benefits of digital interventions, our research will pave the way for more efficient and cost-effective mental healthcare services, benefiting both patients and healthcare systems.

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
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

入选标准

  • Put on the waiting list for mental health outpatient treatment in the active study period.
  • Willing to participate in the study
  • Over 18 years
  • Understand written and spoken Norwegian

排除标准

  • In need of acute help

研究组 & 干预措施

Digital pre-therapy informational intervention (StartHjelp).

Experimental

Patients gets access to StartHjelp, an app which gradually present treatment relevant information while the patient is on waiting list for mental health outpatient services.

干预措施: Digital pre-therapy patient education program (StartHjelp) (Behavioral)

Control group

Active Comparator

The control group gets sent all the same information as the intervention group in written form, by mail.

干预措施: Comparator intervention (Behavioral)

结局指标

主要结局

Knowledge and treatment preferences

时间窗: measured on T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks)

Knowledge will be measured by five questions. All questions are introduced by "how much knowledge do you have about" (how outpatient clinics work; what happens in therapy; self management and user participation; patient rights; treatment options available to you). These questions are answered on a six-point ordinal scale ranging from "Nothing" to "Very much". After these 5 questions a follow up question "do you know what type of treatment you want?", answered either "yes", "no", or "don't know", is asked. If the answer is "yes" the patient is prompted to write what it is that they want.

Patient satisfaction

时间窗: measured on T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)

Patient satisfaction with the client satisfaction questionnaire (CSQ). The CSQ prompts the patient to evaluate different aspects of the care received with an 4 point ordinal scale (very dissatisfied, somewhat dissatisfied, somewhat satisfied, very satisfied).

Patient activation

时间窗: measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks)

Patient activation measure 13 will be used. This questionaire measures patient activation by asking about knowledge, skills, and ability to manage one's own health, and health care usage. It consists of 13 items which is answered on an 4 point ordinal scale (Strongly disagree, somewhat disagree, somewhat agree, and strongly agree. Respondents have the option to answer "not applicable to me" as well.

次要结局

  • Intentions for patient involvement(measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks))
  • Expectations(measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks))
  • Patient enablement(measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks))
  • Level of functioning(measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks))
  • Mental health(measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks))
  • Perceived stress(measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks))
  • Health related Quality of life(measured on T0 (baseline; at 0 weeks), T1 (after randomization, before intervention; up to 2 weeks), T2 (after intervention; up to 8 weeks), T3 (12 months follow up; up to 60 weeks))

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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