Affective Based Integrated Care for Better Quality of Life.Pilot Implementation. Site1: Primary Care Madrid, Spain.

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.

Conditions

• Chronic Disease

Interventions

DEVICE

TeNDER tool

The TeNDER intervention consists of the use of the TeNDER technological tool. It is a web application that integrates all the functionalities of biosensors to facilitate patient self-monitoring, caregiver care and monitoring and management in the daily work of healthcare professionals. Each participant will use the sensor that suits their needs: Sleep quality detector; Position sensor; Smart band; Smart watch; Microphone and speaker; rgb (real sense) sensor; Binary door and window sensor; Environmental sensor.

Sponsors & Collaborators

• Universidad Politecnica de Madrid

  collaborator OTHER

• Foundation for Biomedical Research and Innovation

  collaborator OTHER

• Gerencia de Atención Primaria, Madrid

  lead OTHER_GOV

Principal Investigators

• Federico Álvarez · Universidad Politecnica de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-20

Primary Completion

2023-04-30

Completion

2023-04-30

Countries

• Spain

Study Locations