Evidence map›Paper›PMID 37399054›Full record

ArticleJMIR research protocols2023

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.

Cristina María Lozano Hernández, Rodrigo Medina-García, Mª Canto de Hoyos-Alonso, Araceli Garrido-Barral, César Minué Lorenzo, Teresa Sanz-Cuesta, Javier Serrano, Alberto Del Rio Ponce, Tomas Gómez-Gascón, Isabel Del Cura-González and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05681065 (Affective Based Integrated Care for Better Quality of Life), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05681065 nacompletednot on this map

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

TypeinterventionalSponsorGerencia de Atención Primaria, MadridRan2021 to 2023Enrolled534ConditionsChronic DiseaseArmsTeNDER tool
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Cristina María Lozano HernándezResearch Unit, Primary Health Care Management, Madrid, Spain.ORCID 0000-0002-6981-303X
Rodrigo Medina-GarcíaResearch Unit, Primary Health Care Management, Madrid, Spain.ORCID 0000-0002-3186-5299
Mª Canto de Hoyos-Alonso *Research Network on Chronicity, Primary Care and Health Promotion, Madrid, Spain.ORCID 0000-0002-1409-893X
Araceli Garrido-Barral *Primary Health Care Management, Barrio del Pilar Primary Health Care Centre, Madrid, Spain.ORCID 0000-0003-4864-5177
César Minué Lorenzo *Research Network on Chronicity, Primary Care and Health Promotion, Madrid, Spain.ORCID 0000-0002-8015-3378
Teresa Sanz-Cuesta *Research Unit, Primary Health Care Management, Madrid, Spain.ORCID 0000-0001-8791-8030
Javier Serrano *Visual Telecommunications Application Research Group, Signals, Systems and Radiocommunications Department, Universidad Politécnica, Madrid, Spain.ORCID 0000-0003-2111-187X
Alberto Del Rio Ponce *Visual Telecommunications Application Research Group, Signals, Systems and Radiocommunications Department, Universidad Politécnica, Madrid, Spain.ORCID 0000-0002-6832-4381
Tomas Gómez-Gascón *Biosanitary Research and Innovation Foundation of Primary Care, Madrid, Spain.ORCID 0000-0003-0801-4995
Isabel Del Cura-GonzálezResearch Unit, Primary Health Care Management, Madrid, Spain.ORCID 0000-0002-3931-5304
TeNDER Group Primary CareSee Acknowledgments, .

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAmong chronic diseases, cognitive, neurological, and cardiovascular impairments are becoming increasingly prevalent, generating a shift in health and social needs. Technology can create an ecosystem of care integrated with microtools based on biosensors for motion, location, voice, and expression detection that can help people with chronic diseases. A technological system capable of identifying symptoms, signs, or behavioral patterns could provide notification of the development of complications of disease. This would help the self-care of patients with chronic disease and save health care costs, promoting the autonomy and empowerment of patients and their caregivers, improving their quality of life (QoL), and providing health professionals with monitoring tools.

objectiveThe main objective of this study is to evaluate the effectiveness of a technological system (the TeNDER system) to improve quality of life in patients with chronic diseases: Alzheimer disease, Parkinson disease, and cardiovascular disease.

methodsA multicenter, randomized, parallel-group clinical trial will be conducted with a follow-up of 2 months. The scope of the study will be the primary care health centers of the Community of Madrid belonging to the Spanish public health system. The study population will be patients diagnosed with Parkinson disease, Alzheimer disease, and cardiovascular disease; their caregivers; and health professionals. The sample size will be 534 patients (380 in the intervention group). The intervention will consist of the use of the TeNDER system. The system will monitor the patients by means of biosensors, and their data will be integrated into the TeNDER app. With the information provided, the TeNDER system will generate health reports that can be consulted by patients, caregivers, and health professionals. Sociodemographic variables and technological affinity will be measured, as will views on the usability of and satisfaction with the TeNDER system. The dependent variable will be the mean difference in QoL score between the intervention and control groups at 2 months. To study the effectiveness of the TeNDER system in improving QoL in patients, an explanatory linear regression model will be constructed. All analyses will be performed with the 95% CI and robust estimators.

resultsEthics approval for this project was received on September 11, 2019. The trial was registered on August 14, 2020. Recruitment commenced in April 2021, and the expected results will be available during 2023 or 2024.

conclusionsThis clinical trial among patients with highly prevalent chronic illnesses and the people most involved in their care will provide a more realistic view of the situation experienced by people with long-term illness and their support networks. The TeNDER system is in continuous development based on a study of the needs of the target population and on feedback during its use from the users: patients, caregivers, and primary care health professionals.

trial registrationClinicalTrials.gov NCT05681065; https://clinicaltrials.gov/ct2/show/NCT05681065. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47331.

Indexed as

caregiverschronic diseasecognitive impairmentenvironmental monitoringhealth professionalsmonitoringprimary carepublic healthquality of lifetechnological developmentTeNDER

Identifiers

PMID37399054
PMCPMC10365573

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.