An Innovative Disease-net Management Model for Non-communicable Diseases: a System for Integrated Home-care and Assisted Rehabilitation for Wellbeing
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Activation of Patients as measured by Patient Activation Measure 13 (PAM13) scale
研究概览
简要总结
The SIDERA^B telerehabilitation system is enabled by a multi-domain, multi-device platform providing at home multi-component rehabilitation, targeting cardiovascular (Chronic Heart Failure, CHF), pulmonary (Chronic Obstructive Pulmonary Disease, COPD) and neurodegenerative (Parkinson Disease, PD) chronic diseases. The rehabilitation program embeds engagement activities for patient and caregiver, to empower appropriation of the SIDERA^B care routines and fuel their well-being resources.
The multidisciplinary layering of SIDERA^B is reflected in the validation protocol including a) clinical and well-being evaluation through a cross-over study confronting usual care with the SIDERA^B activities; b) technological evaluation: Health Technology Assessment for organizational, legal and equity impacts; c) economic evaluation: process mapping and budget impact analysis to define a sustainable reimbursement process for the innovative telerehabilitation pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •presence of comorbidities that may prevent you from undertaking a secure home program or determining clinical instability (i.e. severe orthopedic or severe cognitive deficits).
- •presence of risk conditions for safety under strain in patients with CHF (i.e. severe symptomatic aortic stenosis, evidence of ischemia due to minimal/low-intensity efforts).
- •COPD patients who do not need rehabilitation treatment (GOLD 1 / A class) or with severe COPD (GOLD 4 / D class)
- •COPD patients with overlap with other respiratory diseases or not in treatment or in the absence of good ventilatory compensation in the last 6 months
- •COPD with global respiratory failure with PaCO2> 55 mmHg
- •PD patients with other neurological pathologies or with severe psychiatric complications
- •pathological score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test <17.54; Conti et al., 2015).
结局指标
主要结局
Change in Activation of Patients as measured by Patient Activation Measure 13 (PAM13) scale
时间窗: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
Patient Activation Measure 13 (PAM13) is a 13-item scale that assesses a person's underlying knowledge, skills and confidence integral to managing his or her health and healthcare. PAM13 total score ranging from 0 to 100. Higher values represent a better outcome. Specifically, individuals in the lowest activation level do not yet understand the importance of their role in managing their health and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.
Change in activity and participation as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
时间窗: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
WHODAS 2.0 covers six domains of functioning including Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Scores assigned to each item are on a 5-point scale ranging from (0) "none" to (4) "extreme" with higher scores indicating a higher disability. The 36-item version will be administered and both summary scores (score range 0-144 with higher numbers indicating higher disability) and domain-specific scores for the six different functioning domains (score range 0-24 for each domain with higher numbers indicating higher disability) will be considered.
次要结局
- Change in resilience as measured by Connor-Davidson ResIlience SCale (CD-RISC 10-item version).(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in health status scores as measured by St George's Respiratory Questionnaire (SGRQ) only in patients with COPD.(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in care-relationship as Measured by Mutuality Scale (MS)(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Changes in affect as measured by Positive-Negative Affect Schedule (PANAS)(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in patient's self-rated health as measured by EuroQol five dimensions (5D) and five levels (5L)(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in health status scores as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ; Green et al., 2000; ad. it.: Miani et al., 2003) only in patients with Chronic Heart Failure(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in general cognitive function as measured by the Montreal Cognitive Assessment (MoCA) test only in Parkinson's disease group.(Baseline, post treatment (up to 3 or 4 months))
- Change in health-related quality of life as measured by Parkinsons' Disease (PD) Questionnaire (PDQ) only in PD patients(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Changes in scores of environmental mastery as measured by Psychological well-being scale (PWB)(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in Dispositional Optimism as measured by Life Orientation Test-Revised (LOT-R).(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Maintenance or improvement of Aerobic Capacity and Gait using 6' Minute Walking Test (6MWT)(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Changes in Balance, Functional Mobility and Strength measured by 30 Second Sit to Stand Test only CHF(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in motor functionality as measured by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part-III only in Parkinson's Disease group(Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months))
- Change in executive functions as measured by Picture Interpretation test 360 (PIT360) only in Parkinson's disease group.(Baseline, post treatment (up to 3 or 4 months))
- Maintaining the Forced expiratory volume in the 1st second (FEV1%) as measured by spirometry (only in COPD patients)(Baseline, post treatment (up to 3 or 4 months))
- Maintaining cardiovascular performance as measured by echocardiography(Baseline, post treatment (up to 3 or 4 months))