Clinical trial NCT05681065: Affective Based Integrated Care for Better Quality of Life.Pilot Implementation. Site1: Primary Care Madrid, Spain.
Official title: Affective Based Integrated Care for Better Quality of Life (TeNDER).Pilot Implementation. Site 1: Primary Care Madrid, Spain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Chronic Disease
e-health
Quality of Life
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Politecnica de Madrid
name: Foundation for Biomedical Research and Innovation
First posted: 2023-01-11
Enrollment: 534
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Design: randomised, open-label, multicentre, parallel-group clinical trial with 2-month follow-up.

Patients in the intervention group will be fitted with the TeNDER system device best suited to the patient's needs, in addition to routine clinical practice. Patients in the control group will be treated according to standard clinical practice.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Methodology

Design: randomised, open-label, multicentre, parallel-group clinical trial with 2-month follow-up.

Patients in the intervention group will be fitted with the TeNDER system device best suited to the patient's needs, in addition to routine clinical practice. Patients in the control group will be treated according to standard clinical practice.

Sample size. The European consortium has proposed a sample size of 1766 patients (1031 in the Control Group and 735 in the Intervention Group). Those responsible for the technological development have considered that the tool will allow an improvement in Quality of Life (QoL) measured with the Short Form-36 Health Survey questionnaire of 6 points between the groups. According to previous studies consulted, the standard deviation of QoL in the population with the chronic diseases under study (PD, AD and CVD) varies between 16 and 27 \[23-25\]. For the power calculation, we have used the highest value of this standard deviation. Therefore, this sample size will allow a power of 98.8% to detect ≥6 differences in the overall score of the Short Form-36 Health Survey questionnaire if they exist.

The calculations were performed using a freely available software developed by public institutions for epidemiologists and other health professionals for the management of tabulated data.

In Primary Care of the Madrid Health Service, 534 patients will be included (380 in the Intervention Group and 254 in the Control Group). By pathology they will be: 80 patients with PD, 100 patients with AD and 360 patients with CVD.

Recruitment:

In each institution of the consortium, recruitment will be carried out according to its internal organisation.

For the Madrid Health Service institution, it is defined below:

Selection of centres and professionals: In Primary Care in Madrid, 5 health centres have been selected, including a total of 187 professionals (doctors and nurses) who will be offered to participate in the study. Based on experience in previous studies, we expect a participation rate of 45%, which means 84 participating professionals. If necessary, the number of participating centres will be expanded to reach the required sample size of patients and professionals.

Professionals will enter the study on a voluntary basis and after signing an informed consent form.

Recruitment of patients and carers:

Each participating professional will recruit 8 patients from their quota (5 with CVD, 1 with PD and 2 with AD). Recruitment will be done consecutively. Patients with some degree of dependence (PD and AD) will be recruited together with the caregiver, with the prior informed consent of both.

Participants must sign the informed consent before being included in the study. For this purpose, during the recruitment interview, the professionals will provide all the information about the study in written form and accompanied by a detailed verbal explanation, making sure that they understand it. You will be offered the information sheet to take home and share it with the people you consider important for the decision, at the same time as you will be offered the resolution of any doubts that may arise.

Eligibility criteria: 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.

PATIENTS:

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).

General Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in quality of life (PATIENT-ALL)
timeFrame: baseline and 1 month after intervention
Secondary outcomes:
measure: Socio-demographic characteristics(PATIENT-ALL)
timeFrame: baseline
measure: Main disease (PATIENT-ALL)
timeFrame: baseline
measure: Technological affinity (PATIENT-ALL)
timeFrame: baseline
measure: Change in autonomy (PATIENT-ALL)
timeFrame: baseline and 1 month after intervention
measure: Usability (PATIENT-INTERVENTION GROUP)
timeFrame: 1 month after intervention
measure: Satisfaction (PATIENT-INTERVENTION GROUP)
timeFrame: 1 month after intervention
measure: Potential reductions in visits to health services (PATIENT-INTERVENTION GROUP)
timeFrame: 1 month after intervention
Other outcomes:
measure: Socio-demographic characteristics(CAREGIVERS)
timeFrame: baseline
measure: Technological affinity(CAREGIVERS)
timeFrame: baseline
measure: Main disease on charge(CAREGIVERS)
timeFrame: baseline
measure: Change in quality of life (CAREGIVERS)
timeFrame: baseline and 1 month after intervention
measure: Change in satisfaction with the care provided (CAREGIVERS)
timeFrame: baseline and 1 month after intervention
measure: Usability (CAREGIVERS)
timeFrame: 1 month after intervention
measure: Satisfaction (CAREGIVERS)
timeFrame: 1 month after intervention
measure: Potential reductions in visits to health services (CAREGIVERS)
timeFrame: 1 month after intervention
measure: Socio-demographic characteristics (PROFESSIONALS)
timeFrame: baseline
measure: Technological affinity (PROFESSIONALS)
timeFrame: baseline
measure: Change in work overload (PROFESSIONALS)
timeFrame: baseline and 1 month after intervention
measure: Usability (PROFESSIONALS)
timeFrame: 1 month after intervention
measure: Satisfaction (PROFESSIONALS)
timeFrame: 1 month after intervention
measure: Potential reductions in visits to health services (PROFESSIONALS)
timeFrame: 1 month after intervention
Locations:
city: Madrid
country: Spain
facility: Gerencia de atención primaria
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Federico Álvarez
role: STUDY_DIRECTOR
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