Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Patient Enrollment (Feasibility)
研究概览
简要总结
Our objective in the proposed project is to: (a) operationalize and determine the feasibility and acceptability of a trial where clinic multi-disciplinary clinic (MDC) visits are audio/video recorded and shared with patients with ALS and their caregivers; (b) gather preliminary data examining the impact of routinely adding audio/video recordings of clinic visits to UC on self-management ability and other behavioral, health and health services outcomes at baseline (T0) and other regular interviews from enrollment (T1= 1 Week, T2= 3 Months); and (c) identify factors pertinent to the acceptability of our study protocol and the audio/video recording of visits.
详细描述
We will conduct a single-site, two-arm, parallel group, patient-randomized, controlled, pilot trial with 3-month follow up, to determine the feasibility, acceptability, and potential effectiveness of sharing audio/video recordings of multidisciplinary ALS clinics with patients and their caregivers. We will recruit 24 patients with ALS and their caregivers over a recruitment period of 1 year. We are primarily interested in determining the feasibility of the trial and acceptability of the audio/video intervention. We will also explore the impact on the patients' ability to self-manage their care as well as exploratory outcomes, at baseline (T0 = pre-visit), at T1 (1 week), and at T2 (3 months).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed and primarily treated for Amyotrophic Lateral Sclerosis (ALS)
- •Aged 18 years or greater
- •Can communicate in English (verbally, on a computer, or with assistance)
- •Have email
- •Have internet access
- •Willing to have their multidisciplinary clinic visit audio/video recorded for a 3 month period
排除标准
- •Those without the capacity to provide consent, either themselves or via proxy
研究组 & 干预措施
VIDEO
Participants receive access to video recordings of their clinic visits
干预措施: HealthPAL (Other)
Usual Care
Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary
结局指标
主要结局
Patient Enrollment (Feasibility)
时间窗: Study Completion, an average of 1 year
Meeting the targeted recruitment number and rate (two patients per month over a 12 month period)
Intervention Fidelity (Feasibility)
时间窗: Three months
The proportion of ALS MDC (multidisciplinary clinic) patients in the intervention arm that received the VIDEO intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented.
Patient use of the Intervention (Acceptability)
时间窗: Three months
The proportion of ALS MDC (multidisciplinary clinic) patients in the intervention arm who used the recording between the day of receipt and the three-month follow up
次要结局
- Change from baseline in Patient Satisfaction, as measured by the Patient Satisfaction Questionnaire-18 (PSQ-18)(Baseline, one week, three months)
- Change from baseline in adherence to treatment, as measured by the Medical Outcomes Study - General Adherence(Baseline, one week, three months)
- Change from baseline in adherence to medications, as measured by the Adherence to Refills and Medications Scale - 7 (ARMS-7)(Baseline, one week, three months)
- Change from baseline in adherence to physical therapy, as measured by the Exercise Adherence Rating Scale (EARS)(Baseline, one week, three months)
- Change from baseline in anxiety, as measured by the Generalized Anxiety Disorder - 7 (GAD-7)(Baseline, three months)
- Change from baseline in functional status, as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)(Baseline, one week, three months)
- Change from baseline in depression, as measured by the Patient Health Questionnaire - 8 (PHQ-8)(Baseline, three months)
- Level of Communication in the Visit, as measured by the Interpersonal Processes of Care (IPC)(One week)
- Level of literacy, as measured by the Single Item Literacy Screener(Baseline)
- Change in caregiver burden, as measured by the Burden Scale for Family Caregivers - Short (BSFC-s)(Baseline, one week, three months)
- Change in caregiver preparedness, as measured by the Preparedness for Caregiving Scale(Baseline, one week, three months)
- Change in self-efficacy, as measured by the Self Efficacy for Managing Chronic Disease scale(Baseline, one week, three months)
- Feasibility of the Intervention, as measured by the Feasibility of Intervention Metric (FIM)(Three months from baseline)
- Acceptability of the Intervention, as measured by the Acceptability of Intervention Metric (AIM)(Three months from baseline)
研究者
Paul J. Barr
Associate Professor, The Dartmouth Institute for Health Policy and Clinical Practice
Dartmouth-Hitchcock Medical Center