Medication AdherenceAPPROACHNCT05719870
A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults
A study testing Educational training in people with Medication Adherence and Aging, run by University Hospital of Ferrara at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Medication Adherence, Aging, Multidisciplinary Communication
- What is being tested?
- Educational training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2022to 28 Feb 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients discharged in long-term care facilities or other acute or post-acute wards
- No consent to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Geriatric Unit of Ferrara Hospital
Ferrara, 44126
Caterina Trevisan, 0532239572, caterina.trevisan@unife.it
Stefano Volpato
- Recruiting
Geriatric Unit of the Padua Central Hospital
Padova, 35128
Giuseppe Sergi, 0498218492, giuseppe.sergi@unipd.it
Bruno Micael Zanforlini
About this study
Official title: A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults at Hospital Discharge
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.
Read the detailed 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.
- Being tested
- Educational training
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival >7 days. Receives: Behavioral: Educational training |
| Control group | No intervention | Patients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival >7 days. The control group will be discharged following standard care procedures, and will receive only appropriate corrections and clarifications in case mistakes in the comprehension of the medical recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of medical recommendation at hospital discharge
number of mistakes in recalling the prescribed therapy
Measured: At baseline (corresponding to hospital discharge)
Adherence to medical recommendations given at hospital discharge
number of discrepancies in taking the prescribed therapy
Measured: 7 days after hospital discharge
Adherence to the recommendations provided by the occupational therapist at hospital discharge
number of days per week of recommendations' adherence
Measured: 7 days after hospital discharge
Secondary outcomes (4)
Mortality
Assessment of vital status through hospital records and telephone interviews
Measured: 7, 30 and 90 days after hospital discharge
Number of falls
Evaluation through structured telephone interviews
Measured: 30 and 90 days after hospital discharge
Number of emergency department visits
Evaluation through structured telephone interviews
Measured: 30 and 90 days after hospital discharge
Number of rehospitalizations
Evaluation through structured telephone interviews
Measured: 30 and 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Mar 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to the 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. Over 30 and 90 days from discharge, data on falls, rehospitalizations and vital status will be collected through hospital records.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Sponsor
- Investigators
- Cateriina Trevisan, MD, PhD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719870
- Sponsor's protocol ID
- 947/2021/SPER/AOUFe
- Acronym
- APPROACH
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zanforlini BM, Sambo S, Devita M, Cignarella A, Vezzali F, Sturani S, Grandieri A, Noale M, Siviero P, Limongi F, Volpato S, Sergi G, Trevisan C; APPROACH working group. A multidisciplinary approach to improve adherence to medical recommendations in older adults at hospital discharge: The APPROACH study protocol. PLoS One. 2024 Apr 30;19(4):e0297238. doi: 10.1371/journal.pone.0297238. eCollection 2024.
PubMed 38687693
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults at Hospital Discharge
- ClinicalTrials.gov ID
- NCT05719870
- Acronym / sponsor ID
- APPROACH / 947/2021/SPER/AOUFe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 9 Feb 2023 (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 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to the 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. Over 30 and 90 days from discharge, data on falls, rehospitalizations and vital status will be collected through hospital records.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Educational trainingPatients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival >7 days. |
| Control group | No intervention | –Patients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival >7 days. The control group will be discharged following standard care procedures, and will receive only appropriate corrections and clarifications in case mistakes in the comprehension of the medical recommendations. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients discharged in long-term care facilities or other acute or post-acute wards
- No consent to participate in the study.
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 |
|---|---|---|
| Educational trainingThe 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. | Behavioural | Intervention group |
Primary outcome
Comprehension of medical recommendation at hospital discharge
Time frame: At baseline (corresponding to hospital discharge)
number of mistakes in recalling the prescribed therapy
Adherence to medical recommendations given at hospital discharge
Time frame: 7 days after hospital discharge
number of discrepancies in taking the prescribed therapy
Adherence to the recommendations provided by the occupational therapist at hospital discharge
Time frame: 7 days after hospital discharge
number of days per week of recommendations' adherence
4 secondary outcomes
Mortality
Time frame: 7, 30 and 90 days after hospital discharge
Number of falls
Time frame: 30 and 90 days after hospital discharge
Number of emergency department visits
Time frame: 30 and 90 days after hospital discharge
Number of rehospitalizations
Time frame: 30 and 90 days after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 38687693Zanforlini BM, Sambo S, Devita M, Cignarella A, Vezzali F, Sturani S, Grandieri A, Noale M, Siviero P, Limongi F, Volpato S, Sergi G, Trevisan C; APPROACH working group. A multidisciplinary approach to improve adherence to medical recommendations in older adults at hospital discharge: The APPROACH study protocol. PLoS One. 2024 Apr 30;19(4):e0297238. doi: 10.1371/journal.pone.0297238. eCollection 2024.
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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.
Cateriina Trevisan, MD, PhD principal investigator
Università degli Studi di Ferrara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational training in people with Medication Adherence and Aging, run by University Hospital of Ferrara at 2 sites in Italy.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Sergi, MD, PhD (0498218492, giuseppe.sergi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of medical recommendation at hospital discharge (time frame: At baseline (corresponding to hospital discharge)). The study lists 3 primary outcomes in all. 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 NCT05719870, which also lists 1 linked publication.
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 9 Feb 2023.