Evaluate the Value of Telehomecare for Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 975
- 试验地点
- 2
- 主要终点
- Recovery Assessment Scale - Revised
研究概览
简要总结
This is a mixed methods study that evaluates the effectiveness of the Big White Wall (BWW) online community and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 1000 participants that are randomized to an immediate treatment group or a delayed treatment group. The primary outcome includes a change in total and subscale scores on the Recovery Assessment Scale. Qualitative interviews with various stakeholders will explore issues relating to successful implementation.
详细描述
The study consists of a pragmatic randomized controlled trial (RCT) with a nested comparative effectiveness arm to assess the value of intervention extension, with concurrent Realist Evaluation. The pragmatic randomized trial will assess whether the intervention (the Big White Wall) works when introduced into a public health or clinical setting, i.e., in real life conditions. The qualitative realist evaluation will assess the contextual influences and strategies by which the Big White Wall is adopted or rejected.
- Pragmatic Randomized Control Trial (RCT) with nested comparative effectiveness arm:
The RCT will include a delayed treatment crossover control. The immediate treatment group (ITG) will get access to the BWW at time of enrollment and have continuous access for a period of 3 months. The delayed treatment group (DTG) will have no access for the first 3 months, then receive access to the BWW for 3 consecutive months. A 2:1 allocation ratio will be used to randomized participants to ITG or DTG. After 3 months of intervention, ITG participants will have the opportunity to opt-in to an intervention extension arm. Those who opt-in will be randomized at a 1:1 ratio to receive an additional 3 months of BWW or no additional intervention.
Objective:
To determine the incremental benefit and cost-effectiveness of the BWW for patients with mental health problems who seek care at hospital-based mental health programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •16 or older
- •Referred or assessed for a mental health problem (any diagnosis may be considered, but main target is individuals with mood or anxiety symptoms and related difficulties)
- •Able to provide informed consent
- •Willing and able to access an on-line mental health intervention
- •Has or is willing to obtain and use an email address (the study can support participants to get access to an email address if needed)
- •Able to read English
- •Able to navigate an on-line tool independently or with minimal assistance
- •If relevant:
- •Being discharged from the emergency department (ED) or prompt care clinic
- •Clinician assessing patient feels the BWW may be useful (applies to ED and prompt care)
排除标准
- •Symptoms or behaviours that the assessing clinician feels may be disruptive or negatively impactful for the individual or others on the BWW
研究组 & 干预措施
Immediate Treatment Group
The Immediate Treatment Group will receive access to the study intervention - the Big White Wall, immediately after consenting for a total duration of 3 months.
干预措施: Big White Wall (BWW) (Other)
Delayed Treatment Group
The Delayed Treatment Group will have no access to the study intervention - the Big White Wall for the first 3 months, then receive access to the BWW for 3 consecutive months.
干预措施: Big White Wall (BWW) (Other)
Immediate Treatment Group - Extension
Immediate Treatment Group participants who opt in to the nested study and are randomized to the The Immediate Treatment Group - Extension, will receive access to the Big White Wall for an additional 3 months (months 4-6), immediately after receiving the initial 3 months of access.
干预措施: Big White Wall (BWW) (Other)
Immediate Treatment Group - No Extension
Immediate Treatment Group participants who opt in to the nested study and are randomized to The Immediate Treatment Group - No extension, will not receive extended access to the Big White Wall.
结局指标
主要结局
Recovery Assessment Scale - Revised
时间窗: 3 months
Mental health recovery, outcome is total score.
次要结局
- PHQ-9(3 months)
- EQ-5D-5L - VAS(3 months)
- Recovery Assessment Scale - Revised, Subscales(3 months)
- GAD-7(3 months)
- Community Integration Questionnaire (CIQ)(3 months)
- EQ-5D-5L- 5 dimension score(3 months)