Chronic Disease Clinical Trial
— Health_CircuitOfficial title:
Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization
Verified date | February 2021 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | April 10, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Physical or psychological health problems that prevent the use of the tool and that the patient does not have the help of a caregiver. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unplanned visits | Number of unplanned primary care and hospital visits | 3 months | |
Secondary | Service utilization measures | number of primary care and hospital visits, number of remote resolutions and number of hospitalizations | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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. | 3 months | |
Secondary | Equipment failures | Number of equipment failures according to blockage, breakage, acceleration or delay and unidentified failures | 3 months | |
Secondary | Software failures | Number of software failures described as slowdown in execution, information delay, command rows or information not available | 3 months | |
Secondary | Errors in execution | Number of errors in execution (wrong sequence action) described as omission, forward jump, backward jump, repetition, inversion or incorrect action | 3 months | |
Secondary | 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 | 3 months | |
Secondary | Errors due to failures in the organization | Number of errors due to failures in the organization described as anthropometric problems or inadequate interface | 3 months | |
Secondary | 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 | 3 months | |
Secondary | Number of entries to the application (app) per patient | Number of entries to the application (app) per patient | 3 months | |
Secondary | 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 | 3 months | |
Secondary | Number of video calls | Number of video calls i. Number of total video calls. ii. Number of patients who have contacted via video call. | 3 months | |
Secondary | Number of patients who have accessed the conditions of use | Number of patients who have accessed the conditions of use | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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). | 3 months | |
Secondary | 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). | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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. | 3 months | |
Secondary | Patient mHealth experience | Two open questions regarding negative and positive aspects of the use of the computer tool | 3 months | |
Secondary | Professional mHealth experience | Two open questions regarding negative and positive aspects of the use of the computer tool | 3 months | |
Secondary | Number of clinical diagnoses in app users | number of high priority clinical diagnoses in app users according to CIE10 in medical history | 3 months | |
Secondary | Degree of severity of the symptom | Degree of severity of the symptom measured according to very mild, mild, neutral, severe or very serious | 3 months | |
Secondary | Duration of the symptom | Duration of the symptom expressed in hours, days or weeks | 3 months | |
Secondary | Number of professionals that the manager has contacted through the app | Number of professionals that the manager has contacted through the app | 3 months | |
Secondary | Number of interactions between professionals through the app | Number of interactions between professionals through the app | 3 months | |
Secondary | Number of solutions provided only by the manager | Number of solutions provided only by the manager regarding the number of total solutions | 3 months | |
Secondary | Number of solutions provided by the primary care professional | Number of solutions provided by the primary care professional regarding the number of total solutions | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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 | 3 months |
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