Chronic DiseaseTeNDER_Site1NCT05681065
Affective Based Integrated Care for Better Quality of Life.Pilot Implementation. Site1: Primary Care Madrid, Spain.
A study testing TeNDER tool in people with Chronic Disease, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- TeNDER tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Inability to move and move around at home (bedridden).
- Alcoholism or drug addiction.
- Life expectancy < 6 months.
- 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
- 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.
Who cannot join
- 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:
- Caregivers not able to consent.
- Caregivers not aware of the daily needs of patients.
Show all 10Show fewer
- PROFESSIONALS:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affective Based Integrated Care for Better Quality of Life (TeNDER).Pilot Implementation. Site 1: Primary Care Madrid, Spain.
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:
Read more
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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- TeNDER tool
- Keywords
- Chronic Disease, e-health, Quality of Life
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeNDER toolDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard practice. Patients will receive the usual clinical care based on the transmission of information and advice, and review according to the Clinical Practice Guidelines corresponding to the various chronic diseases presented by the patient. |
| Intervention Group | Experimental | Standard practice. Patients will receive the usual clinical care based on the transmission of information and advice, and review according to the Clinical Practice Guidelines corresponding to the various chronic diseases presented by the patient. In addition, these participants will be provided with the TeNDER technological tool. The TeNDER intervention consists of the use of the TeNDER technological tool. It is a web application that integrates all the functionalities of the biosensors to facilitate patient self-monitoring, caregiver care and monitoring and management in the daily work of health professionals. Receives: Device: TeNDER tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 1 month after intervention
Secondary outcomes (7)
Socio-demographic characteristics(PATIENT-ALL)
Gender (male or female), age (number)
Measured: baseline
Main disease (PATIENT-ALL)
Main disease shall be recorded as AD (Alzheimer disease, ) PD (Parkinson disease) and CVD (cardiovascular disease)
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline and 1 month after intervention
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.
Measured: 1 month after intervention
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.
Measured: 1 month after intervention
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.
Measured: 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start20 Apr 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Universidad Politecnica de Madrid, Foundation for Biomedical Research and Innovation
- Responsible party
- Principal investigator, Cristina Lozano Hernández, Gerencia de Atención Primaria, Madrid
- Investigators
- Federico Álvarez, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681065
- Sponsor's protocol ID
- 39/20
- Other IDs
- 875325
- Acronym
- TeNDER_Site1
- Status last verified
- Sep 2023
- First submitted
- 3 Jan 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25048354Haslbeck 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.
PubMed 26711458Davis 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.
PubMed 27847686Mills 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.
PubMed 27242377Ornstein 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.
PubMed 24004703Konig 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.
PubMed 23768192Torous 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.
PubMed 27150677Mohr 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.
PubMed 28375728Raggi 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.
PubMed 27434374Huckvale 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.
PubMed 31508498Kitsiou 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.
PubMed 28249025Tu 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.
PubMed 28650957Benda 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.
PubMed 26517867Geschke 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.
PubMed 23567410Vilagut 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.
PubMed 15860162
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Based Integrated Care for Better Quality of Life (TeNDER).Pilot Implementation. Site 1: Primary Care Madrid, Spain.
- ClinicalTrials.gov ID
- NCT05681065
- Acronym / sponsor ID
- TeNDER_Site1 / 39/20
- Conditions
- Chronic Disease
- Keywords
- Chronic Disease, e-health, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Universidad Politecnica de Madrid, Foundation for Biomedical Research and Innovation
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard practice. Patients will receive the usual clinical care based on the transmission of information and advice, and review according to the Clinical Practice Guidelines corresponding to the various chronic diseases presented by the patient. |
| Intervention Group | Experimental | Device: TeNDER toolStandard practice. Patients will receive the usual clinical care based on the transmission of information and advice, and review according to the Clinical Practice Guidelines corresponding to the various chronic diseases presented by the patient. In addition, these participants will be provided with the TeNDER technological tool. The TeNDER intervention consists of the use of the TeNDER technological tool. It is a web application that integrates all the functionalities of the biosensors to facilitate patient self-monitoring, caregiver care and monitoring and management in the daily work of health professionals. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
- 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.
Key exclusion criteria (10 listed)
- 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 not able to consent.
- Caregivers not aware of the daily needs of patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeNDER toolThe 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. | Device | Intervention Group |
Primary outcome
Change in quality of life (PATIENT-ALL)
Time frame: baseline and 1 month after intervention
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.
7 secondary outcomes
Socio-demographic characteristics(PATIENT-ALL)
Time frame: baseline
Main disease (PATIENT-ALL)
Time frame: baseline
Technological affinity (PATIENT-ALL)
Time frame: baseline
Change in autonomy (PATIENT-ALL)
Time frame: baseline and 1 month after intervention
Usability (PATIENT-INTERVENTION GROUP)
Time frame: 1 month after intervention
Satisfaction (PATIENT-INTERVENTION GROUP)
Time frame: 1 month after intervention
Potential reductions in visits to health services (PATIENT-INTERVENTION GROUP)
Time frame: 1 month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 25048354Violan 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.
- Background: PubMed 26711458Haslbeck 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.
- Background: PubMed 27847686Davis 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.
- Background: PubMed 27242377Mills 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.
- Background: PubMed 24004703Ornstein 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.
- Background: PubMed 23768192Konig 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.
- Background: PubMed 27150677Torous 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.
- Background: PubMed 28375728Mohr 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.
- Background: PubMed 27434374Raggi 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.
- Background: PubMed 31508498Huckvale 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.
- Background: PubMed 28249025Kitsiou 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.
- Background: PubMed 28650957Tu 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.
- World Health Organization (WHO) apps websiteLink provided by the sponsor.
- World Health Organization (WHO) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Álvarez study director
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeNDER tool in people with Chronic Disease, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (PATIENT-ALL) (time frame: baseline and 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681065, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.