Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05681065
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2023-01-03
Brief Title:
Affective Based Integrated Care for Better Quality of LifePilot Implementation Site1 Primary Care Madrid Spain
Sponsor:
Gerencia de Atención Primaria Madrid
Organization:
Gerencia de Atención Primaria Madrid
Study Overview
Official Title:
Affective Based Integrated Care for Better Quality of Life TeNDERPilot Implementation Site 1 Primary Care Madrid Spain
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TeNDER_Site1
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 Parkinsons disease PD Alzheimers disease or other dementias AD and cardiovascular disease CVD their caregivers and social-health professionals will be studied
Sample size n 1766 patients 1031 control735 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 andor effect modifiers One model will be fitted for men and one for women An intention-to-treat analysis will be performed
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 Parkinsons disease PD Alzheimers disease or other dementias AD and cardiovascular disease CVD their caregivers and social-health professionals will be studied
Sample size n 1766 patients 1031 control735 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 andor 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 patients 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 988 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
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 patients 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 988 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 875325 | OTHER_GRANT | Europe H2020 | None |