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

NCT05681065 | Completed

• 2 other identifiers: 39/20875325
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 1

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 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

Keywords

Chronic Disease; e-health; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Socio-demographic characteristics(PATIENT-ALL)

  baseline

• Main disease (PATIENT-ALL)

  baseline

• Technological affinity (PATIENT-ALL)

  baseline

• Change in autonomy (PATIENT-ALL)

  baseline and 1 month after intervention

• Usability (PATIENT-INTERVENTION GROUP)

  1 month after intervention

Other Outcomes (14)

• Socio-demographic characteristics(CAREGIVERS)

  baseline

• Technological affinity(CAREGIVERS)

  baseline

• Main disease on charge(CAREGIVERS)

  baseline

Study Arms (2)

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.

Device: TeNDER tool

Interventions

TeNDER tool DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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:
• 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
• Caregivers not able to consent.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Universidad Politecnica de Madrid: collaborator
• Foundation for Biomedical Research and Innovation: collaborator

Study Sites (1)

Gerencia de atención primaria

Madrid, 28035, Spain

Location

Related Publications (18)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 28375728 BACKGROUND

• 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.

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• 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.

  PMID: 31508498 BACKGROUND

• 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.

  PMID: 28249025 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 17235093 BACKGROUND

• Medina-Garcia R, Lopez-Rodriguez JA, Lozano-Hernandez CM, Ruiz Bejerano V, Criscio P, Del Cura-Gonzalez I; TeNDER Atencion Primaria Group. A Technological Tool Aimed at Self-Care in Patients With Multimorbidity: Cross-Sectional Usability Study. JMIR Hum Factors. 2024 Apr 5;11:e46811. doi: 10.2196/46811.

  PMID: 38578675 DERIVED

• Lozano Hernandez CM, Medina-Garcia R, de Hoyos-Alonso MC, Garrido-Barral A, Minue Lorenzo C, Sanz-Cuesta T, Serrano J, Del Rio Ponce A, Gomez-Gascon T, Del Cura-Gonzalez I; TeNDER Group Primary Care. Improvement in Quality of Life With the Use of a Technological System Among Patients With Chronic Disease Followed Up in Primary Care (TeNDER Project): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 3;12:e47331. doi: 10.2196/47331.

  PMID: 37399054 DERIVED

Related Links

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

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Federico Álvarez

  Universidad Politecnica de Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher on European projects. Family and Community Nurse Specialist

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 11, 2023
• Study Start: April 20, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)