Affective Based Integrated Care for Better Quality of Life.Pilot Implementation. Site1: Primary Care Madrid, Spain. — TeNDER_Site1  

Chronic Disease Clinical Trial

Official title: Affective Based Integrated Care for Better Quality of Life (TeNDER).Pilot Implementation. Site 1: Primary Care Madrid, Spain.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Disease

• NCT number: NCT05681065
• Study type: Interventional
• Source: Gerencia de Atención Primaria, Madrid
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Completion date: April 30, 2023