Affective Based Integrated Care for Better Quality of Life (TeNDER).Pilot Implementation. Site 1: Primary Care Madrid, Spain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- Change in quality of life (PATIENT-ALL)
研究概览
简要总结
Objective: To evaluate the effectiveness of the TeNDER tool compared to usual practice in improving Quality of Life in patients with chronic diseases, according to type of disease and gender.
Methodology:
Design: randomised, open-label, multicentre, parallel-group clinical trial with 2-month follow-up.
Setting: health centres, homes, hospitals, socio-health centres and patient associations belonging to the participating countries.
Population: Patients with chronic diseases such as Parkinson's disease (PD), Alzheimer's disease or other dementias (AD) and cardiovascular disease (CVD); their caregivers and social-health professionals will be studied.
Sample size: n= 1,766 patients (1031 control/735 intervention).
Variables: The main outcome variable is the change in patient quality of life Short Form-36 Health Survey (SF-36). In addition, sociodemographic variables, technological affinity, usability, satisfaction and potential reductions in visits to health services after the intervention were collected in all study subjects. The change in patient autonomy after the intervention, the change in caregiver satisfaction with the care provided and the change in work overload in professionals were also studied.
Analysis: A descriptive analysis will be performed, a comparison of groups will be made at T1, a mean difference of global QoL and by dimensions will be calculated at T2 with its 95% Confident Interval (CI). For the main outcome, a multilevel linear regression model will be used with the dependent variable being the Quality of Life score at 60 days (T2) and the independent variable the group to which it belongs (control / TENDER) adjusted for possible confounding variables and/or effect modifiers. One model will be fitted for men and one for women. An intention-to-treat analysis will be performed.
详细描述
Hypothesis and Objective
Operational hypothesis: The use of the TeNDER tool by patients with chronic diseases increases their Quality of Life, as measured by the Short Form-36 Health Survey (SF-36), by at least 6 points, compared to usual practice.
Primary Aim: To evaluate the effectiveness of the TeNDER tool compared to usual practice in improving Quality of Life in patients with chronic diseases.
Secondary objectives:
- To evaluate the effectiveness of the TeNDER tool compared to usual practice in improving Quality of Life according to type of illness and gender.
- To evaluate the effectiveness of the TeNDER tool on caregiver overload.
- To describe the adherence and satisfaction of patients, carers and professionals with the TeNDER tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main study population is patients with Parkinson's disease (PD), Alzheimer's disease or other dementias (AD) and cardiovascular disease (CVD). Data will also be collected from their caregivers and professionals.
- •General Inclusion Criteria:
- •Understand the local language of the country in which it takes place.
- •Have a reference person or caregiver (if dependent).
- •Agree to participate in the study, understand it and have signed the informed consent form.
- •Inclusion criteria for disease:
- •AD: Persons expressing subjective cognitive compliant and Mini-Mental State Examination (MMSE) score of 19 to 28 pts, or having diagnosis of disease-causing dementia (with MMSE score of 19 to 28 pts) or Diagnosis of Alzheimer's according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- •PD: Confirmed diagnosis of Parkinson's disease. All patients will provide a report with an assessment from the neurologist.
- •CVD: Patient that presents one of the following: cardiovascular failure grade II-III New York Heart Association (NYHA); coronary heart disease (both stable and acute coronary artery disease with or without S-T segment elevation); Atrial Fibrillation; Cardiac Pacemaker Carrier; Cerebral Stroke (ischaemic and haemorrhagic).
排除标准
- •Patients whose caregiver is not willing to participate / help; Patients / caregivers are not willing to work with the technologies used in this project.
- •Patient and caregiver considered by the recruiting professional to be unable to follow the requirements of the study.
- •Inability to move and move around at home (bedridden).
- •Alcoholism or drug addiction.
- •Life expectancy < 6 months.
- •Exclusion criteria for disease:
- •AD: Advanced stages of the disease (GDS 6-7).
- •PD: Parkinsonism secondary to vascular disease or treatment; Parkinsonism syndromes (Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Syndrome); dementia with Lewy bodies (DLB).
- •CVD: acute coronary artery disease less than 4 weeks ago; severe aortic stenosis.
- •CAREGIVERS:
- •Inclusion criteria:
- •To be able to consent and to comply with at least one of the following requisites:
- •To be employed by a public or private company or directly by the patients to provide direct care and thus support daily activities.
- •To live with and/or take care of a relative (or other close relationship) affected by Parkinson's disease or Alzheimer's disease or/and others forms of dementia or CVD
- •To provide logistic support to a family member or a close friend affected by Parkinson's disease or Alzheimer's disease or/and others forms of dementia or CVD.
- •Express readiness in the use of technologies to use the devices
- •Exclusion criteria:
- •Caregivers not able to consent.
- •Caregivers not aware of the daily needs of patients.
- •PROFESSIONALS:
- •Inclusion criteria:
- •- To be able to consent and to be qualified and working in a medical or social area specialized in the care or support of persons with Parkinson's, Alzheimer's or/and other forms of dementia and cardiovascular diseases.
- •Exclusion criteria:
- •Not working as a professional involved in the care or support of AD, PD, CVD patients.
- •Working practice and environment not connected to Alzheimer's' and/or other forms of dementia, Parkinson's' disease or cardiovascular diseases.
- •Conflict of interest.
结局指标
主要结局
Change in quality of life (PATIENT-ALL)
时间窗: baseline and 1 month after intervention
Quality of life will be measured at baseline and at the end of the TeNDER intervention (after 1 month) and the change between the two measures will be studied. Health-related quality of life as measured by the Short Form-36 Health Survey (SF-36). This questionnaire contains 36 items and 8 dimensions: Physical Function (10); Physical Role (4); Bodily Pain (2); General Health (5); Vitality (4); Social Function (2); Emotional Role (3) and 2 summary components (Physical and Mental). The score ranges from 0 to 100, where the higher the score the better the health status.
次要结局
- Main disease (PATIENT-ALL)(baseline)
- Change in autonomy (PATIENT-ALL)(baseline and 1 month after intervention)
- Satisfaction (PATIENT-INTERVENTION GROUP)(1 month after intervention)
- Potential reductions in visits to health services (PATIENT-INTERVENTION GROUP)(1 month after intervention)
- Technological affinity (PATIENT-ALL)(baseline)
- Socio-demographic characteristics(PATIENT-ALL)(baseline)
- Usability (PATIENT-INTERVENTION GROUP)(1 month after intervention)
研究者
Cristina Lozano Hernández
Researcher on European projects. Family and Community Nurse Specialist
Gerencia de Atención Primaria, Madrid