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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05719870
Other study ID # 947/2021/SPER/AOUFe
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date February 28, 2023

Study information

Verified date June 2022
Source University Hospital of Ferrara
Contact Giuseppe Sergi, MD, PhD
Phone 0498218492
Email giuseppe.sergi@unipd.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background and overall goal: Poor comprehension and medication adherence are common in older people, especially after hospitalizations, in case of changes or prescriptions of new therapeutic regimes. The aim of this project is to evaluate the effectiveness of a multidomain intervention with an integrated care approach, in improving medication adherence in older people after hospital discharge. A secondary aim is investigate the determinants of poor comprehension and medication adherence in such individuals. Target population: The project will involve older patients hospitalized in a Geriatric Department and discharged at home, and (when present) their caregivers. Methods and assessments: Upon hospital discharge, data from the comprehensive geriatric assessment and information on the present hospitalization and prescribed therapies will be collected for all participants. The comprehension of medical recommendations reported in the discharge summary will be evaluated for all patients/caregiver before and after the routine explanation by treating physicians. Participants will be then randomized in intervention vs. control group. The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments. Control group will follow usual care. After 7 days medication adherence will be assessed for both study groups through structured phone interviews. At 30 and 90 days from discharge, data on falls, rehospitalizations and vital status will be collected through hospital records.


Description:

Background and overall goal: Poor comprehension and medication adherence are common in older people, especially after hospitalizations, in case of changes or prescriptions of new therapeutic regimes. The aim of this project is to evaluate the effectiveness of a multidomain intervention with an integrated care approach, in improving medication adherence in older people after hospital discharge. Moreover, a secondary aim is to investigate the determinants of poor comprehension and medication adherence in such individuals. Target population: The project will involve older patients hospitalized in a Geriatric Department and discharged at home, and (when present) their caregivers. Methods and assessments: Upon hospital discharge, data from the comprehensive geriatric assessment and information on the present hospitalization and prescribed therapies will be collected for all participants. The comprehension of medical recommendations reported in the discharge summary will be evaluated for all patients/caregiver before and after the routine explanation by treating physicians. Participants will be then randomized in intervention vs. control group. The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments. Control group will follow usual care. After 7, 30 and 90 days, data on medication adherence, falls, rehospitalizations and vital status will be assessed for both study groups through structured phone interviews and hospital records.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility For the enrolment of the study participants, we will regularly monitor ward admissions, and potential eligibility of the patients will be evaluated by using the following inclusion criteria: - Patients hospitalized in the Geriatric Units of the Padua and Ferrara University Hospitals - Age 60 years or older - Patients living in the community setting and who will be discharged at home - Expected survival >7 days Exclusion criteria: - Patients discharged in long-term care facilities or other acute or post-acute wards - No consent to participate in the study.

Study Design


Intervention

Behavioral:
Educational training
The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments.

Locations

Country Name City State
Italy Geriatric Unit of Ferrara Hospital Ferrara
Italy Geriatric Unit of the Padua Central Hospital Padova

Sponsors (2)

Lead Sponsor Collaborator
University Hospital of Ferrara University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comprehension of medical recommendation at hospital discharge number of mistakes in recalling the prescribed therapy At baseline (corresponding to hospital discharge)
Primary Adherence to medical recommendations given at hospital discharge number of discrepancies in taking the prescribed therapy 7 days after hospital discharge
Primary Adherence to the recommendations provided by the occupational therapist at hospital discharge number of days per week of recommendations' adherence 7 days after hospital discharge
Secondary Mortality Assessment of vital status through hospital records and telephone interviews 7, 30 and 90 days after hospital discharge
Secondary Number of falls Evaluation through structured telephone interviews 30 and 90 days after hospital discharge
Secondary Number of emergency department visits Evaluation through structured telephone interviews 30 and 90 days after hospital discharge
Secondary Number of rehospitalizations Evaluation through structured telephone interviews 30 and 90 days after hospital discharge
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