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

Chronic Disease Clinical Trial

— TeNDER_Site1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05681065
• Other study ID #: 39/20
• Secondary ID: 875325
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2023
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
Spain	Gerencia de atención primaria	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Foundation for Biomedical Research and Innovation, Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (16)

Benda NM, Seeger JP, Stevens GG, Hijmans-Kersten BT, van Dijk AP, Bellersen L, Lamfers EJ, Hopman MT, Thijssen DH. Effects of High-Intensity Interval Training versus Continuous Training on Physical Fitness, Cardiovascular Function and Quality of Life in Heart Failure Patients. PLoS One. 2015 Oct 30;10(10):e0141256. doi: 10.1371/journal.pone.0141256. eCollection 2015. — View Citation

Davis AA, Racette B. Parkinson disease and cognitive impairment: Five new things. Neurol Clin Pract. 2016 Oct;6(5):452-458. doi: 10.1212/CPJ.0000000000000285. — View Citation

Geschke K, Fellgiebel A, Laux N, Schermuly I, Scheurich A. Quality of life in dementia: impact of cognition and insight on applicability of the SF-36. Am J Geriatr Psychiatry. 2013 Jul;21(7):646-54. doi: 10.1016/j.jagp.2012.12.014. Epub 2013 Feb 6. — View Citation

Haslbeck J, Zanoni S, Hartung U, Klein M, Gabriel E, Eicher M, Schulz PJ. Introducing the chronic disease self-management program in Switzerland and other German-speaking countries: findings of a cross-border adaptation using a multiple-methods approach. BMC Health Serv Res. 2015 Dec 28;15:576. doi: 10.1186/s12913-015-1251-z. — View Citation

Huckvale K, Venkatesh S, Christensen H. Toward clinical digital phenotyping: a timely opportunity to consider purpose, quality, and safety. NPJ Digit Med. 2019 Sep 6;2:88. doi: 10.1038/s41746-019-0166-1. eCollection 2019. — View Citation

Kitsiou S, Pare G, Jaana M, Gerber B. Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews. PLoS One. 2017 Mar 1;12(3):e0173160. doi: 10.1371/journal.pone.0173160. eCollection 2017. — View Citation

Konig HH, Leicht H, Bickel H, Fuchs A, Gensichen J, Maier W, Mergenthal K, Riedel-Heller S, Schafer I, Schon G, Weyerer S, Wiese B, Bussche Hv, Scherer M, Eckardt M; MultiCare study group. Effects of multiple chronic conditions on health care costs: an analysis based on an advanced tree-based regression model. BMC Health Serv Res. 2013 Jun 15;13:219. doi: 10.1186/1472-6963-13-219. — View Citation

Mills SL, Brady TJ, Jayanthan J, Ziabakhsh S, Sargious PM. Toward consensus on self-management support: the international chronic condition self-management support framework. Health Promot Int. 2017 Dec 1;32(6):942-952. doi: 10.1093/heapro/daw030. — View Citation

Mohr DC, Zhang M, Schueller SM. Personal Sensing: Understanding Mental Health Using Ubiquitous Sensors and Machine Learning. Annu Rev Clin Psychol. 2017 May 8;13:23-47. doi: 10.1146/annurev-clinpsy-032816-044949. Epub 2017 Mar 17. — View Citation

Ornstein SM, Nietert PJ, Jenkins RG, Litvin CB. The prevalence of chronic diseases and multimorbidity in primary care practice: a PPRNet report. J Am Board Fam Med. 2013 Sep-Oct;26(5):518-24. doi: 10.3122/jabfm.2013.05.130012. — View Citation

Perera R, Heneghan C, Yudkin P. Graphical method for depicting randomised trials of complex interventions. BMJ. 2007 Jan 20;334(7585):127-9. doi: 10.1136/bmj.39045.396817.68. — View Citation

Raggi A, Corso B, Minicuci N, Quintas R, Sattin D, De Torres L, Chatterji S, Frisoni GB, Haro JM, Koskinen S, Martinuzzi A, Miret M, Tobiasz-Adamczyk B, Leonardi M. Determinants of Quality of Life in Ageing Populations: Results from a Cross-Sectional Study in Finland, Poland and Spain. PLoS One. 2016 Jul 19;11(7):e0159293. doi: 10.1371/journal.pone.0159293. eCollection 2016. — View Citation

Torous J, Kiang MV, Lorme J, Onnela JP. New Tools for New Research in Psychiatry: A Scalable and Customizable Platform to Empower Data Driven Smartphone Research. JMIR Ment Health. 2016 May 5;3(2):e16. doi: 10.2196/mental.5165. — View Citation

Tu XJ, Hwang WJ, Ma HI, Chang LH, Hsu SP. Determinants of generic and specific health-related quality of life in patients with Parkinson's disease. PLoS One. 2017 Jun 26;12(6):e0178896. doi: 10.1371/journal.pone.0178896. eCollection 2017. — View Citation

Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish. — View Citation

Violan C, Foguet-Boreu Q, Flores-Mateo G, Salisbury C, Blom J, Freitag M, Glynn L, Muth C, Valderas JM. Prevalence, determinants and patterns of multimorbidity in primary care: a systematic review of observational studies. PLoS One. 2014 Jul 21;9(7):e102149. doi: 10.1371/journal.pone.0102149. eCollection 2014. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-demographic characteristics(CAREGIVERS)	Gender (male or female), age (number)	baseline
Other	Technological affinity(CAREGIVERS)	This information is collected with a question about their taste for using technology and 6 different levels of response are offered.	baseline
Other	Main disease on charge(CAREGIVERS)	Main disease of the person being cared for. This shall be recorded as AD (Alzheimer disease, ) PD (Parkinson disease) and CVD (cardiovascular disease)	baseline
Other	Change in quality of life (CAREGIVERS)	It will be collected through 11 ad hoc questions focused on the carer. It will be collected at baseline and 1 month after the intervention and the change will be studied.	baseline and 1 month after intervention
Other	Change in satisfaction with the care provided (CAREGIVERS)	By means of a question with different levels of response. It will be collected at baseline and 1 month after the intervention and the change will be studied.	baseline and 1 month after intervention
Other	Usability (CAREGIVERS)	Collected through the validated tool "System Usability Scale". This scale is composed of 10 questions related to satisfaction with usability. The overall score is calculated from the sum of all item scores multiplied by 2.5, and the overall score ranges from 0 to 100.	1 month after intervention
Other	Satisfaction (CAREGIVERS)	Satisfaction with the intervention. This will be studied by means of 4 ad hoc likert-type questions scored 1-5. Where 20 is the highest satisfaction with the tool.	1 month after intervention
Other	Potential reductions in visits to health services (CAREGIVERS)	Through 3 questions, the opinion on the potential of the tool to reduce visits to health services is collected.	1 month after intervention
Other	Socio-demographic characteristics (PROFESSIONALS)	Gender (male or female), age (number)	baseline
Other	Technological affinity (PROFESSIONALS)	This information is collected with a question about their taste for using technology and 6 different levels of response are offered.	baseline
Other	Change in work overload (PROFESSIONALS)	By means of a question with different levels of response. It will be collected at baseline and 1 month after the intervention and the change will be studied.	baseline and 1 month after intervention
Other	Usability (PROFESSIONALS)	Collected through the validated tool "System Usability Scale". This scale is composed of 10 questions related to satisfaction with usability. The overall score is calculated from the sum of all item scores multiplied by 2.5, and the overall score ranges from 0 to 100.	1 month after intervention
Other	Satisfaction (PROFESSIONALS)	Satisfaction with the intervention. This will be studied by means of 4 ad hoc likert-type questions scored 1-5. Where 20 is the highest satisfaction with the tool.	1 month after intervention
Other	Potential reductions in visits to health services (PROFESSIONALS)	Through 3 questions, the opinion on the potential of the tool to reduce visits to health services is collected.	1 month after intervention
Primary	Change in quality of life (PATIENT-ALL)	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.	baseline and 1 month after intervention
Secondary	Socio-demographic characteristics(PATIENT-ALL)	Gender (male or female), age (number)	baseline
Secondary	Main disease (PATIENT-ALL)	Main disease shall be recorded as AD (Alzheimer disease, ) PD (Parkinson disease) and CVD (cardiovascular disease)	baseline
Secondary	Technological affinity (PATIENT-ALL)	This information is collected with a question about their taste for using technology and 6 different levels of response are offered.	baseline
Secondary	Change in autonomy (PATIENT-ALL)	The difference in autonomy between baseline and after the intervention (1 month after) will be studied. Autonomy at each time point will be studied by means of 6 ad hoc likert-type questions scored 4-0. Where 24 is total autonomy and 0 is no autonomy.	baseline and 1 month after intervention
Secondary	Usability (PATIENT-INTERVENTION GROUP)	Collected through the validated tool "System Usability Scale". This scale is composed of 10 questions related to satisfaction with usability. The overall score is calculated from the sum of all item scores multiplied by 2.5, and the overall score ranges from 0 to 100.	1 month after intervention
Secondary	Satisfaction (PATIENT-INTERVENTION GROUP)	Satisfaction with the intervention. This will be studied by means of 4 ad hoc likert-type questions scored 1-5. Where 20 is the highest satisfaction with the tool.	1 month after intervention
Secondary	Potential reductions in visits to health services (PATIENT-INTERVENTION GROUP)	Through 3 questions, the opinion on the potential of the tool to reduce visits to health services is collected.	1 month after intervention

External Links

•   World Health Organization (WHO) apps website
•   World Health Organization (WHO) website