Multiple Chronic ConditionsHealth_CircuitNCT04056663
Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization
A study testing Health-Circuit mobile application in people with Multiple Chronic Conditions and Chronic Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Background - There is a high potential for hospitalization prevention through: (i) a greater continuity of care, achieved by facilitating collaborative work among professionals at different levels of care, and (ii) improving the self-efficacy of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Chronic Conditions, Chronic Disease
- What is being tested?
- Health-Circuit mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2019to 10 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the SELFIE study.
- Accepting to participate in the study and sign the consent.
- In the intervention group, having a "smart phone" or "Tablet" that can support the use of the computer tool (versions of the operating systems Android or iOS compatible with the patient's application) and having an internet connection.
Who cannot join
- Physical or psychological health problems that prevent the use of the tool and that the patient does not have the help of a caregiver.
Trial locations and contacts
1 site in 1 country.
About this study
Background - There is a high potential for hospitalization prevention through: (i) a greater continuity of care, achieved by facilitating collaborative work among professionals at different levels of care, and (ii) improving the self-efficacy of patients. For both objectives, the support of appropriate information and communication technologies is essential. The study raises the hypothesis that an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, will facilitate a greater continuity of care and an improvement in patients' self-efficacy.
Objective - Analysis of Health-Circuit's potential for improving the continuity of care and self-efficacy of chronic patients at risk of hospitalization.
Read more
Material and methods - Controlled, single-blinded, randomized trial by primary care teams, with a 2:1 intervention-control ratio. The first phase of the study (September-November 2019) will be carried out in 75 patients from the primary care area of Barcelona Esquerra under the influence of Hospital Clínic of Barcelona (CAPSBE, 110k inhabitants). In the intervention group, the patients, and the corresponding healthcare professionals, will communicate and collaborate though Health-Circuit, while the control group will receive conventional treatment. In a second phase (beginning December 2019), the study will be extended to the entire healthcare area of Barcelona Esquerra (AISBE, 520k inhabitants).
Expected results - From a clinical perspective, a reduction in the number of urgent face-to-face visits is expected at: (i) Hospital; (ii) Primary Care, or, (iii) Primary Care Emergency Centers, due to better continuity of care and greater self-efficacy of patients. However, the results sought in Phase I of the study will be, fundamentally: (i) the evaluation of the usability and acceptability of Health-Circuit for patients and professionals, and (ii) the analysis of the potential of the digital tool for the management of complex clinical processes with the help of intelligent bots. In phase II of the study, the central objectives will be (i) increase in the capacity to resolve events, and (ii) improvement of patients' self-efficacy.
Read the detailed description
The present investigation develops in the framework of the EU project CONNECARE "Personalized Connected Care for Complex Chronic Patients (H2020 - BHC25 - 689802), whose registration number in the medical research ethics committee of Hospital Clínic of Barcelona is HCB / 2018/0803. CONNECARE assumes that (i) the improvement of the continuity of care, associated with facilitating collaborative work among professionals of different levels of care, and, (ii) the increase in patients' self-efficacy, results in an optimization of the management of chronic patients with the consequent decrease in unplanned consultations, whether at primary care or at the hospital. This necessarily leads to an increase in the resolving capacity of primary care teams and an increase in the prevention of hospitalizations.
Although the role of digital technologies, as an element of support for integrated care services, is well-demonstrated, at present, we still do not have adequate digital tools that provide adequate support for collaborative work between professionals and, in turn, encourage the empowerment for self-management of patients. We understand as such, technologies: (i) compliant with the General Data Protection Regulation (GDPR), (ii) interoperable with existing health information systems, and, that (iii) facilitate the adaptive and collaborative management of chronic patients.
The present study evaluates the potential of an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, for the improvement of the management of chronic patients, with the consequent increase of the resolving capacity of the community health teams. Health-Circuit allows patients and professionals to interact, bilaterally or in groups, from various information systems and devices, regardless of their physical location. The base technology platform, Circuit, is robust (TRL 9), located in the cloud (private, mixed or public) and complies with the General Data Protection Regulation (GDPR). Circuit allows multimedia corporate communication (chat, call, video-call, file exchange, etc.) between healthcare levels, increasing coordination among professionals with the consequent improvement of health outcomes. Its potential can be increased in the future with the use of intelligent Chatbots to guide patients and professionals through complex care processes, providing decision support for personalised service selection by means of enhanced health risk assessment and patient stratification.
- Conditions
- Multiple Chronic Conditions, Chronic Disease
- Being tested
- Health-Circuit mobile application
- Keywords
- Artificial Intelligence, Continuity of Patient Care
- Medical subject headings
- Multiple Chronic Conditions, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-Circuit mobile applicationBehavioural
Health-Circuit as a collaborative tool between professionals and patient and professionals
| Study group | Role | What they receive |
|---|---|---|
| Health-Circuit mobile application | Experimental | The intervention contemplates. (i) management of unexpected events; and, (ii) empowering the patient to improve self-efficacy.
Users of the intervention arm will have the Health-Circuit mobile application, which will offer them the possibility of contacting the case managers to notify a health event at any time and that this can be resolved by their health professionals through Health -Circuit. The improvement of the patient's self-efficacy for the management of their health problems through the use of Health-Circuit is considered through the virtual visits of follow-up with the manager, the possibility of interacting with the manager and the consultation of the shared documents reminders of the action plan agreed with the patient. Receives: Behavioral: Health-Circuit mobile application |
| Conventional treatment | No intervention | Patients assigned to this group will follow conventional treatment. Once the three months have passed, we will contact you again to ask the pertinent questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned visits
Number of unplanned primary care and hospital visits
Measured: 3 months
Secondary outcomes (30)
Service utilization measures
number of primary care and hospital visits, number of remote resolutions and number of hospitalizations
Measured: 3 months
Change in The Health Empowerment Scale
The instrument retained 8 items, scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of health-related empowerment.
Measured: 3 months
Change in the Fantastic Lifestyle questionnaire
This questionnaire contains 25 closed items that you explore nine related physical, psychological and social categories or domains to the lifestyle. It presents three response options with a numerical value of 0 to 2 for each category, and they are graded using a Likert scale, with a score of 0 to 100 points. Taking as a cut-off point the average of the qualifications proposed by the authors of the instrument five levels of qualification stratify the behavior: (<39 points = danger exists, 40 to 59 points = bad, 60 to 69 points = regular , 70 to 84 points = good, 85 to 100 points = excellent) lifestyle. The lower the score, the greater the need for change.
Measured: 3 months
Equipment failures
Number of equipment failures according to blockage, breakage, acceleration or delay and unidentified failures
Measured: 3 months
Software failures
Number of software failures described as slowdown in execution, information delay, command rows or information not available
Measured: 3 months
Errors in execution
Number of errors in execution (wrong sequence action) described as omission, forward jump, backward jump, repetition, inversion or incorrect action
Measured: 3 months
Number of errors due to the participant's temporary functions
Number of errors due to the participant's temporary functions described as forgetfulness, incorrect memory, incomplete memory, random actions, stoppage of actions, suspended task, task not completed, objective forgotten or loss of orientation
Measured: 3 months
Errors due to failures in the organization
Number of errors due to failures in the organization described as anthropometric problems or inadequate interface
Measured: 3 months
Number of participants in the study with respect to the total of potential participants
Number of participants in the study with respect to the total of potential participants of: i. Patients ii. Professionals
Measured: 3 months
Number of entries to the application (app) per patient
Number of entries to the application (app) per patient
Measured: 3 months
Number of contacts with clinical professionals responsible for managing the case
Number of contacts with clinical professionals responsible for managing the case that will be contacted through the technological tool (mHealth manager): i. Number of total contacts. ii. Number of patients who have contacted
Measured: 3 months
Number of video calls
Number of video calls i. Number of total video calls. ii. Number of patients who have contacted via video call.
Measured: 3 months
Number of patients who have accessed the conditions of use
Number of patients who have accessed the conditions of use
Measured: 3 months
Change in Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
It consists of four questions selected from the domain Collaboration between care of the Nijmegen Continuity of Care Questionnaire. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
Measured: 3 months
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
The Net Promoter Score is calculated based on the answers to a single question. The result is calculated by dividing the percentage of promoters (who have a score of 9-10) minus the percentage of detractors (who have a score of 0-6). The percentage of "liabilities" (which obtained a score of 7-8) is not included in the NPS calculation. The NPS varies between -100 and +100. A positive score is considered good. The three custom made general satisfaction question is scored on a 5-point Likert scale that ranges from 0 (poor) to 10 (Good).
Measured: 3 months
Professional satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
The Net Promoter Score is calculated based on the answers to a single question. The result is calculated by dividing the percentage of promoters (who have a score of 9-10) minus the percentage of detractors (who have a score of 0-6). The percentage of "liabilities" (which obtained a score of 7-8) is not included in the NPS calculation. The NPS varies between -100 and +100. A positive score is considered good. The three custom made general satisfaction question is scored on a 5-point Likert scale that ranges from 0 (poor) to 10 (Good).
Measured: 3 months
Patient mHealth tool usability assessed by the System Usability Scale
The System Usability Scale is a 10 item questionnaire with 5 response options. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
Measured: 3 months
Professional mHealth tool usability by the System Usability Scale
The System Usability Scale is a 10 item questionnaire with 5 response options. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
Measured: 3 months
Patient mHealth experience
Two open questions regarding negative and positive aspects of the use of the computer tool
Measured: 3 months
Professional mHealth experience
Two open questions regarding negative and positive aspects of the use of the computer tool
Measured: 3 months
Number of clinical diagnoses in app users
number of high priority clinical diagnoses in app users according to CIE10 in medical history
Measured: 3 months
Degree of severity of the symptom
Degree of severity of the symptom measured according to very mild, mild, neutral, severe or very serious
Measured: 3 months
Duration of the symptom
Duration of the symptom expressed in hours, days or weeks
Measured: 3 months
Number of professionals that the manager has contacted through the app
Number of professionals that the manager has contacted through the app
Measured: 3 months
Number of interactions between professionals through the app
Number of interactions between professionals through the app
Measured: 3 months
Number of solutions provided only by the manager
Number of solutions provided only by the manager regarding the number of total solutions
Measured: 3 months
Number of solutions provided by the primary care professional
Number of solutions provided by the primary care professional regarding the number of total solutions
Measured: 3 months
Number of solutions that has been a virtual visit
Number of solutions that has been a virtual visit with the primary care professional regarding the total number of solutions
Measured: 3 months
Number of solutions that has been a classroom visit
Number of solutions that has been a classroom visit with the primary care professional regarding the total number of solutions
Measured: 3 months
Number of referrals to the emergency department regarding the total number of solutions
Number of referrals to the emergency department regarding the total number of solutions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start12 Sep 2019
- Primary completion31 Dec 2019
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Herranz, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056663
- Sponsor's protocol ID
- Health-Circuit Clinic
- Acronym
- Health_Circuit
- Status last verified
- Feb 2021
- First submitted
- 22 Jul 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Aymerich J, Hernandez C, Alonso A, Casas A, Rodriguez-Roisin R, Anto JM, Roca J. Effects of an integrated care intervention on risk factors of COPD readmission. Respir Med. 2007 Jul;101(7):1462-9. doi: 10.1016/j.rmed.2007.01.012. Epub 2007 Mar 6.
PubMed 17339106Tistad M, Lundell S, Wiklund M, Nyberg A, Holmner A, Wadell K. Usefulness and Relevance of an eHealth Tool in Supporting the Self-Management of Chronic Obstructive Pulmonary Disease: Explorative Qualitative Study of a Cocreative Process. JMIR Hum Factors. 2018 Oct 26;5(4):e10801. doi: 10.2196/10801.
PubMed 30368440Lupianez-Villanueva F, Anastasiadou D, Codagnone C, Nuno-Solinis R, Garcia-Zapirain Soto MB. Electronic Health Use in the European Union and the Effect of Multimorbidity: Cross-Sectional Survey. J Med Internet Res. 2018 May 3;20(5):e165. doi: 10.2196/jmir.7299.
PubMed 29724702Wildenbos GA, Maasri K, Jaspers M, Peute L. Older adults using a patient portal: registration and experiences, one year after implementation. Digit Health. 2018 Sep 2;4:2055207618797883. doi: 10.1177/2055207618797883. eCollection 2018 Jan-Dec.
PubMed 30186619Steele Gray C, Wodchis WP, Upshur R, Cott C, McKinstry B, Mercer S, Palen TE, Ramsay T, Thavorn K; Project Collaborators And Technology Partner, QoC Health Inc. Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool. JMIR Res Protoc. 2016 Jun 24;5(2):e126. doi: 10.2196/resprot.5756.
PubMed 27341765Matui P, Wyatt JC, Pinnock H, Sheikh A, McLean S. Computer decision support systems for asthma: a systematic review. NPJ Prim Care Respir Med. 2014 May 20;24:14005. doi: 10.1038/npjpcrm.2014.5.
PubMed 24841952Leijten FRM, Struckmann V, van Ginneken E, Czypionka T, Kraus M, Reiss M, Tsiachristas A, Boland M, de Bont A, Bal R, Busse R, Rutten-van Molken M; SELFIE consortium. The SELFIE framework for integrated care for multi-morbidity: Development and description. Health Policy. 2018 Jan;122(1):12-22. doi: 10.1016/j.healthpol.2017.06.002. Epub 2017 Jun 20.
PubMed 28668222Vázquez R, Martínez M. Ministerio de Industria, Energía y Turismo Entidad Pública Empresarial Red.es Observatorio Nacional de las Telecomunicaciones y de la Sociedad de la Información [Internet]. 2016. p. 0-200. Available from: https://www.ontsi.red.es/ontsi/sites/ontsi/files/los_ciudadanos_ante_la_e-sanidad.pdf
Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124.
PubMed 14712543Ramirez-Velez R, Agredo RA. [The Fantastic instrument's validity and reliability for measuring Colombian adults' life-style]. Rev Salud Publica (Bogota). 2012 Mar-Apr;14(2):226-37. doi: 10.1590/s0124-00642012000200004. Spanish.
PubMed 23250366Serrani Azcurra DJ. Elders Health Empowerment Scale: Spanish adaptation and psychometric analysis. Colomb Med (Cali). 2014 Dec 30;45(4):179-85. eCollection 2014 Oct-Dec.
PubMed 25767307Uijen AA, Schellevis FG, van den Bosch WJ, Mokkink HG, van Weel C, Schers HJ. Nijmegen Continuity Questionnaire: development and testing of a questionnaire that measures continuity of care. J Clin Epidemiol. 2011 Dec;64(12):1391-9. doi: 10.1016/j.jclinepi.2011.03.006.
PubMed 21689904Herranz C, Martin-Moreno Banegas L, Dana Muzzio F, Siso-Almirall A, Roca J, Cano I. A Practice-Proven Adaptive Case Management Approach for Innovative Health Care Services (Health Circuit): Cluster Randomized Clinical Pilot and Descriptive Observational Study. J Med Internet Res. 2023 Jun 14;25:e47672. doi: 10.2196/47672.
PubMed 37314850
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization
- ClinicalTrials.gov ID
- NCT04056663
- Acronym / sponsor ID
- Health_Circuit / Health-Circuit Clinic
- Conditions
- Multiple Chronic Conditions, Chronic Disease
- Keywords
- Artificial Intelligence, Continuity of Patient Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 14 Aug 2019 (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.
Background - There is a high potential for hospitalization prevention through: (i) a greater continuity of care, achieved by facilitating collaborative work among professionals at different levels of care, and (ii) improving the self-efficacy of patients. For both objectives, the support of appropriate information and communication technologies is essential. The study raises the hypothesis that an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, will facilitate a greater continuity of care and an improvement in patients' self-efficacy.
Objective - Analysis of Health-Circuit's potential for improving the continuity of care and self-efficacy of chronic patients at risk of hospitalization.
Material and methods - Controlled, single-blinded, randomized trial by primary care teams, with a 2:1 intervention-control ratio. The first phase of the study (September-November 2019) will be carried out in 75 patients from the primary care area of Barcelona Esquerra under the influence of Hospital Clínic of Barcelona (CAPSBE, 110k inhabitants). In the intervention group, the patients, and the corresponding healthcare professionals, will communicate and collaborate though Health-Circuit, while the control group will receive conventional treatment. In a second phase (beginning December 2019), the study will be extended to the entire healthcare area of Barcelona Esquerra (AISBE, 520k inhabitants).
Expected results - From a clinical perspective, a reduction in the number of urgent face-to-face visits is expected at: (i) Hospital; (ii) Primary Care, or, (iii) Primary Care Emergency Centers, due to better continuity of care and greater self-efficacy of patients. However, the results sought in Phase I of the study will be, fundamentally: (i) the evaluation of the usability and acceptability of Health-Circuit for patients and professionals, and (ii) the analysis of the potential of the digital tool for the management of complex clinical processes with the help of intelligent bots. In phase II of the study, the central objectives will be (i) increase in the capacity to resolve events, and (ii) improvement of patients' self-efficacy.
Detailed description
The present investigation develops in the framework of the EU project CONNECARE "Personalized Connected Care for Complex Chronic Patients (H2020 - BHC25 - 689802), whose registration number in the medical research ethics committee of Hospital Clínic of Barcelona is HCB / 2018/0803. CONNECARE assumes that (i) the improvement of the continuity of care, associated with facilitating collaborative work among professionals of different levels of care, and, (ii) the increase in patients' self-efficacy, results in an optimization of the management of chronic patients with the consequent decrease in unplanned consultations, whether at primary care or at the hospital. This necessarily leads to an increase in the resolving capacity of primary care teams and an increase in the prevention of hospitalizations.
Although the role of digital technologies, as an element of support for integrated care services, is well-demonstrated, at present, we still do not have adequate digital tools that provide adequate support for collaborative work between professionals and, in turn, encourage the empowerment for self-management of patients. We understand as such, technologies: (i) compliant with the General Data Protection Regulation (GDPR), (ii) interoperable with existing health information systems, and, that (iii) facilitate the adaptive and collaborative management of chronic patients.
The present study evaluates the potential of an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, for the improvement of the management of chronic patients, with the consequent increase of the resolving capacity of the community health teams. Health-Circuit allows patients and professionals to interact, bilaterally or in groups, from various information systems and devices, regardless of their physical location. The base technology platform, Circuit, is robust (TRL 9), located in the cloud (private, mixed or public) and complies with the General Data Protection Regulation (GDPR). Circuit allows multimedia corporate communication (chat, call, video-call, file exchange, etc.) between healthcare levels, increasing coordination among professionals with the consequent improvement of health outcomes. Its potential can be increased in the future with the use of intelligent Chatbots to guide patients and professionals through complex care processes, providing decision support for personalised service selection by means of enhanced health risk assessment and patient stratification.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health-Circuit mobile application | Experimental | Behavioral: Health-Circuit mobile applicationThe intervention contemplates. (i) management of unexpected events; and, (ii) empowering the patient to improve self-efficacy. Users of the intervention arm will have the Health-Circuit mobile application, which will offer them the possibility of contacting the case managers to notify a health event at any time and that this can be resolved by their health professionals through Health -Circuit. The improvement of the patient's self-efficacy for the management of their health problems through the use of Health-Circuit is considered through the virtual visits of follow-up with the manager, the possibility of interacting with the manager and the consultation of the shared documents reminders of the action plan agreed with the patient. |
| Conventional treatment | No intervention | –Patients assigned to this group will follow conventional treatment. Once the three months have passed, we will contact you again to ask the pertinent questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in the SELFIE study.
- Accepting to participate in the study and sign the consent.
- In the intervention group, having a "smart phone" or "Tablet" that can support the use of the computer tool (versions of the operating systems Android or iOS compatible with the patient's application) and having an internet connection.
Key exclusion criteria (1 listed)
- Physical or psychological health problems that prevent the use of the tool and that the patient does not have the help of a caregiver.
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 |
|---|---|---|
| Health-Circuit mobile applicationHealth-Circuit as a collaborative tool between professionals and patient and professionals | Behavioural | Health-Circuit mobile application |
Primary outcome
Unplanned visits
Time frame: 3 months
Number of unplanned primary care and hospital visits
30 secondary outcomes
Service utilization measures
Time frame: 3 months
Change in The Health Empowerment Scale
Time frame: 3 months
Change in the Fantastic Lifestyle questionnaire
Time frame: 3 months
Equipment failures
Time frame: 3 months
Software failures
Time frame: 3 months
Errors in execution
Time frame: 3 months
Number of errors due to the participant's temporary functions
Time frame: 3 months
Errors due to failures in the organization
Time frame: 3 months
Number of participants in the study with respect to the total of potential participants
Time frame: 3 months
Number of entries to the application (app) per patient
Time frame: 3 months
Number of contacts with clinical professionals responsible for managing the case
Time frame: 3 months
Number of video calls
Time frame: 3 months
Number of patients who have accessed the conditions of use
Time frame: 3 months
Change in Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
Time frame: 3 months
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
Time frame: 3 months
Professional satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
Time frame: 3 months
Patient mHealth tool usability assessed by the System Usability Scale
Time frame: 3 months
Professional mHealth tool usability by the System Usability Scale
Time frame: 3 months
Patient mHealth experience
Time frame: 3 months
Professional mHealth experience
Time frame: 3 months
Number of clinical diagnoses in app users
Time frame: 3 months
Degree of severity of the symptom
Time frame: 3 months
Duration of the symptom
Time frame: 3 months
Number of professionals that the manager has contacted through the app
Time frame: 3 months
Number of interactions between professionals through the app
Time frame: 3 months
Number of solutions provided only by the manager
Time frame: 3 months
Number of solutions provided by the primary care professional
Time frame: 3 months
Number of solutions that has been a virtual visit
Time frame: 3 months
Number of solutions that has been a classroom visit
Time frame: 3 months
Number of referrals to the emergency department regarding the total number of solutions
Time frame: 3 months
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 12 Feb 2021.
- Background: PubMed 17339106Garcia-Aymerich J, Hernandez C, Alonso A, Casas A, Rodriguez-Roisin R, Anto JM, Roca J. Effects of an integrated care intervention on risk factors of COPD readmission. Respir Med. 2007 Jul;101(7):1462-9. doi: 10.1016/j.rmed.2007.01.012. Epub 2007 Mar 6.
- Background: PubMed 30368440Tistad M, Lundell S, Wiklund M, Nyberg A, Holmner A, Wadell K. Usefulness and Relevance of an eHealth Tool in Supporting the Self-Management of Chronic Obstructive Pulmonary Disease: Explorative Qualitative Study of a Cocreative Process. JMIR Hum Factors. 2018 Oct 26;5(4):e10801. doi: 10.2196/10801.
- Background: PubMed 29724702Lupianez-Villanueva F, Anastasiadou D, Codagnone C, Nuno-Solinis R, Garcia-Zapirain Soto MB. Electronic Health Use in the European Union and the Effect of Multimorbidity: Cross-Sectional Survey. J Med Internet Res. 2018 May 3;20(5):e165. doi: 10.2196/jmir.7299.
- Background: PubMed 30186619Wildenbos GA, Maasri K, Jaspers M, Peute L. Older adults using a patient portal: registration and experiences, one year after implementation. Digit Health. 2018 Sep 2;4:2055207618797883. doi: 10.1177/2055207618797883. eCollection 2018 Jan-Dec.
- Background: PubMed 27341765Steele Gray C, Wodchis WP, Upshur R, Cott C, McKinstry B, Mercer S, Palen TE, Ramsay T, Thavorn K; Project Collaborators And Technology Partner, QoC Health Inc. Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool. JMIR Res Protoc. 2016 Jun 24;5(2):e126. doi: 10.2196/resprot.5756.
- Background: PubMed 24841952Matui P, Wyatt JC, Pinnock H, Sheikh A, McLean S. Computer decision support systems for asthma: a systematic review. NPJ Prim Care Respir Med. 2014 May 20;24:14005. doi: 10.1038/npjpcrm.2014.5.
- Background: PubMed 28668222Leijten FRM, Struckmann V, van Ginneken E, Czypionka T, Kraus M, Reiss M, Tsiachristas A, Boland M, de Bont A, Bal R, Busse R, Rutten-van Molken M; SELFIE consortium. The SELFIE framework for integrated care for multi-morbidity: Development and description. Health Policy. 2018 Jan;122(1):12-22. doi: 10.1016/j.healthpol.2017.06.002. Epub 2017 Jun 20.
- BackgroundVázquez R, Martínez M. Ministerio de Industria, Energía y Turismo Entidad Pública Empresarial Red.es Observatorio Nacional de las Telecomunicaciones y de la Sociedad de la Información [Internet]. 2016. p. 0-200. Available from: https://www.ontsi.red.es/ontsi/sites/ontsi/files/los_ciudadanos_ante_la_e-sanidad.pdf
- Background: PubMed 14712543Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124.
- Results publication: PubMed 23250366Ramirez-Velez R, Agredo RA. [The Fantastic instrument's validity and reliability for measuring Colombian adults' life-style]. Rev Salud Publica (Bogota). 2012 Mar-Apr;14(2):226-37. doi: 10.1590/s0124-00642012000200004. Spanish.
- Results publication: PubMed 25767307Serrani Azcurra DJ. Elders Health Empowerment Scale: Spanish adaptation and psychometric analysis. Colomb Med (Cali). 2014 Dec 30;45(4):179-85. eCollection 2014 Oct-Dec.
- Results publication: PubMed 21689904Uijen AA, Schellevis FG, van den Bosch WJ, Mokkink HG, van Weel C, Schers HJ. Nijmegen Continuity Questionnaire: development and testing of a questionnaire that measures continuity of care. J Clin Epidemiol. 2011 Dec;64(12):1391-9. doi: 10.1016/j.jclinepi.2011.03.006.
- Digital toolLink provided by the sponsor.
- Measuring Usability With The System Usability Scale (SUS). Measuring UsabilityLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Multiple Chronic Conditions
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
RecruitingPhase 3
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic Inflammatory Demyelinating Polyneuropathy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-Circuit mobile application in people with Multiple Chronic Conditions and Chronic Disease, run by Hospital Clinic of Barcelona 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 3 inclusion and 1 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 12 Feb 2021. 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?
Unplanned visits (time frame: 3 months). 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 NCT04056663, which also lists 13 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 12 Feb 2021.