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Trial registered on ANZCTR


Registration number
ACTRN12611000347965
Ethics application status
Approved
Date submitted
1/04/2011
Date registered
4/04/2011
Date last updated
28/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An easy intervention to improve short-term adherence to medications in community-dwelling older outpatients. A pilot randomised controlled study.
Scientific title
The effect of an easy intervention versus usual geriatric care in improving adherence to medications in community-dwelling older outpatients.
Secondary ID [1] 259895 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adherence to medications among older outpatients 265495 0
Condition category
Condition code
Public Health 265646 265646 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A quick and easy intervention with the objective to improve adherence to pharmacological treatment. It was applied at the end of the outpatient visit to the person managing the medications (patient or caregiver) who was asked to write down on a sheet of paper the drug regimen that had been prescribed. This was dictated to him/her by the doctor to obtain a schedule of pharmacological treatment in which the times of administration of the drugs were noted along with their dosages. The doctor supervised the operation, making sure that the transcription was correct and clear, and the patient or caregiver was then given the schedule for use at home. This schedule of therapy was set to be used at home for at least 4 weeks.
Intervention code [1] 264321 0
Behaviour
Comparator / control treatment
Usual care, i.e. the standard procedure available at the outpatient geriatric service: the prescribed pharmacological treatment was stated at the end of the medical report and reviewed orally with the person in charge of medications.
Control group
Active

Outcomes
Primary outcome [1] 262438 0
Outcome of the study was taken to be the presence of at least one self-reported adherence error of any kind (i.e. occasional or persistent) at a one-month follow-up. Errors were evaluated by means of a semi-structured interview in which participants were asked to indicate for each of the drugs prescribed i) if it was generally taken/given regularly, ii) if it was occasionally not taken/given because of forgetfulness or temporary unavailability, iii) what were the dosages and times of administration. Moreover, patients/caregivers were asked if they were taking/giving drugs not included in the list they had written under the doctor's dictation.
Timepoint [1] 262438 0
One month after the geriatric outpatient visit.
Secondary outcome [1] 273780 0
Nil
Timepoint [1] 273780 0
Nil

Eligibility
Key inclusion criteria
Being living in the community, taking at least one drug a day, having been prescribed a change in pharmacological treatment during the visit (i.e. at least one drug was added or suspended by the doctor) and – in the case of patients dependent in the management of medications - having with them at the visit the caregiver who was in charge of the administration of drugs.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Being not living at home, not taking medications, not having been prescribed a change in pharmacological treatment during the visit, being dependent in the management of medications without the caregiver who was in charge of the administration of drugs.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3327 0
Italy
State/province [1] 3327 0

Funding & Sponsors
Funding source category [1] 264784 0
University
Name [1] 264784 0
University of Milan
Address [1] 264784 0
via Pace 9, 20122, Milan, Italy
Country [1] 264784 0
Italy
Primary sponsor type
University
Name
University of Milan
Address
via Pace 9, 20122, Milan, Italy
Country
Italy
Secondary sponsor category [1] 263898 0
Hospital
Name [1] 263898 0
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Address [1] 263898 0
Geriatric Medicine Unit, via Pace 9, 20122, Milan
Country [1] 263898 0
Italy

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Complex interventions to improve compliance to pharmacological treatment in older people have given mixed results and are not easily applicable in clinical practice. The aim of this study was to test the short-term efficacy on self-reported medication adherence of an easy intervention in which the patient or caregiver was asked to transcribe the pharmacological treatment while it was dictated to him/her by the doctor. We hypothesize that this kind of intervention can be valuable in improving patients’ adherence to therapy, at least in the short term. Such intervention has the potential to be effective both psychologically and organisationally. Psychologically because it can enhance the sense of empowerment of patients/caregivers by allowing them to play a more active role in the health-care process. Organisationally because it results in a medication schedule in which the dosages and the times of administration of the prescribed drugs have been clearly noted under the doctor’s supervision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32421 0
Address 32421 0
Country 32421 0
Phone 32421 0
Fax 32421 0
Email 32421 0
Contact person for public queries
Name 15668 0
Claudio Bilotta
Address 15668 0
via Pace 9, 20122 Milan
Country 15668 0
Italy
Phone 15668 0
0039 2 55035411
Fax 15668 0
Email 15668 0
claudio.bilotta@gmail.com
Contact person for scientific queries
Name 6596 0
Claudio Bilotta
Address 6596 0
via Pace 9, 20129 Milan
Country 6596 0
Italy
Phone 6596 0
0039 2 55035411
Fax 6596 0
Email 6596 0
claudio.bilotta@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary