Teen Connections for Support From Multidisciplinary Professionals & Peers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Health Survey SF-12v2 (predicts future health services use).
研究概览
简要总结
12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.
详细描述
This research study will test the effect of in-home/mobile HPN support delivered to teen and young adult home parenteral nutrition (HPN) patients and family members over handheld personal computers. Effects on health status, QoL, and fatigue will be assessed over time between groups of study subjects from the ages of 13 through 30 randomized to one of two groups. Group One (intervention group) will receive mConnect, integrated evidence-based interventions (skill-building games, restorative naps & peer support) via mobile iPad and Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary professionals and peers. Group Two (control group) will receive healthy activity information via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection with professionals and peers.
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
入排标准
- 年龄范围
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care) age 13 and older
- •TPN users (also called HPN users) ages 13 through 30 must be receiving intravenous nutrition for a non-malignant short bowel disorder
- •Read, write, speak English and provide informed consent
- •Be able to participate in group clinic visits
排除标准
- •Enteral nutrition dependency only
- •Less than 13 years of age
- •13 through 17 years of age without parental consent
- •Currently enrolled in an intervention study or HPN management program
- •Severe cognitive impairment
- •Disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics
结局指标
主要结局
Health Survey SF-12v2 (predicts future health services use).
时间窗: T5 (12 months: change from T4/8 months)
Physical and mental health status from each person's perspective. 7-Item Likert
Quality of Life (Cantril Ladder)
时间窗: T5 (12 months: change from T4/8 months)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
时间窗: T3 (month 3-4/mConnect intervention period)
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
Beck Depression Inventory-II (BDI-II)
时间窗: T5 (12 months: change from T4/8 months)
Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
次要结局
- Preparedness (measures skills needed for independent HPN home care).(T5 (12 months: change from T4/8 months))
- COOPS Social Support Scale(T5 (12 months: change from T4/8 months))
- Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.(T4 (8 months))