I50 J44 J18 N10 A46
Conditions
Interventions
Group 1: The target group of the study are chronically ill patients over the age of 65 years in acute medical situations. This is a pilot study in which the satisfaction and acceptance of the users (p
Sponsors
Universitätsklinikum Bonn - Studienzentrale SZB - Institut für klinische Chemie und klinische Pharmakologie
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 65 years • Living in the area of coverage • Patients with the ability to follow study instructions and likely to attend and complete all required visits • Written informed consent Social: • Supported by either a nursing service or an informal carer living in the same household • Appropiate Housing Conditions • Informal carer available (at least by telephone) all day • Having social needs, defined as • Barber at least 2 answers in the affirmative + Any Barthel-Score OR • Barthel-Score between 80 and 95 + Barber at least 1 answer in the affirmative OR • Barthel-Score 75 or less + any Barber Medical: COPD exacerbation (without indication for in-patient treatment according to the GP) • physician-diagnosed COPD (defined as FEV1/ FVC <70%) • new exertional dyspnea or worsening of existing exertional dyspnea • necessity of a systemic therapy with antibiotics and/or corticosteroids Decompensated heart failure (without indication for in-patient treatment according to the GP) • physician-diagnosed heart failure (all functional classes) • At least one of the following symptoms o new exertional dyspnea or worsening of existing exertional dyspnea o new peripheral oedema or worsening of existing oedema o increase in weight of = 2 kg within 5 days or less • necessity of new medication with a (additional) diuretic or modification (increase) of an existing diuretic therapy Pneumonia (without indication for in-patient treatment according to the GP) • Suspected pneumonia by the GP PLUS at least one of the following o Corresponding auscultation of the lung o Elevated CRP o Corresponding Chest-x-ray • At least two points in the Charlson Comorbidity Index (CCI) Pyelonephritis (without indication for in-patient treatment according to the GP) • Suspected pyelonephritis by the GP PLUS at least one of the following: o Elevated CRP o Corresponding urine test strip o Corresponding ultrasound • At least two points in the Charlson Comorbidity Index (CCI) Erysipel (without indication for in-patient treatment according to the GP) • Suspected erysipel by the GP • At least two points in the Charlson Comorbidity Index (CCI)
Exclusion criteria
Exclusion criteria: • Patients not able to give consent • Necessity of hospitalization according to the appraisal of the GP • Severe dyspnea • Oxygen saturation < 90% (if measured) • Rapid progression of symptoms • Clouding of conscioussness • Central cyanosis • Uncertain diagnosis • Hypotension, defined as systolic blood pressure < 100 mmHg • Pulmonary oedema • New or hemodynamic relevant arrhythmias (including new atrial fibrillation) • Patients without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial • Patients with implanted pacemaker or ICD-system • Patients with severe mental retardation, psychiatrical disorders or other cognitive impairment resulting in incapability to adequately estimate the risks and benefits of study participitation (e.g. advanced dementia) • Patient lacks suitability for Polycare in estimation of the local Polycare-Team (consisting of staff of SZB and IfH of the UKB)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the ICT system with the System Usability Score (SUS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Satisfaction of all users with the Polycare-service (eCCIS) - Level of satisfaction of the patients regarding the devices (eCCIS) - Number of patients who felt better supervised (questionnaire) - Number of professional and informal carers who find the care provided by the service better/worse than usual (questionnaire) - Level of satisfaction of Mobile App (patients) and Web App (formal and informal carers) (eCCIS) - Level of satisfaction regarding the cooperation between the professional participants (questionnaire + focus group) - Average of use of the devices (retroperspective analysis via system-queries) - Frequency of accessing and duration of use of the Mobile App and Web App (Compliance) (analysis of the use of different components of the system) - Retroperspective Identification of relevant changes in recorded vital signs not detected by the carers (system queries) - Assessment of technical problems occurred at the patient’s home - Number of alerts generated by the system regarding vital signs out of range (system queries) - Number of alerts generated by the system regarding possible interactions in the medication plan (system queries) - Improvement of quality of life during the project (EQ5D) - Improvement of the Carer burden (Zarit) - Improvement of Empowerment (PAM) - Number of Hospitalizations during the project - Assessment of the coordination between the stakeholders (focus group) - Assessment of the impact (positive or negative) on the daily work for the professional carers (questionnaire) - Assessment of the benefit of particular components of the system (questionnaire) | — |
Countries
Germany
Contacts
Public ContactNils Heiland
Uniklinik Bonn - Institut für Hausarztmedizin
Outcome results
None listed