- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05908604
Use of a Robot in Medication Management for Older People's Home Care
The Effect of a Robot in Medication Management for Older People's Home Care: a Non-randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The data were collected using a Working Time Tracking Form, which was developed by professional team for this study. The team included senior lecturer in nursing with medication management competence, head of older people's home care, and home care professional working in older people's home care. The content of the Time Tracking Form was founded on previous literature about the medication management process in home care. The research protocol was planned by the authors before the study and it can be accessed from the corresponding authors on a reasonable request. The home care professionals filled in the Working Time Tracking Form the time in minutes they used for each phase of process i.e. ordering medications, dispensing medications to the doset or dispensing medications to the robot, reconstitution medications, administration of medications in tablets, administration of medications in other routes, medication education, and monitoring the effects of medications. The Working Time Tracking Form was filled in from each client and from each home visit, which included medication management for a five-day period in baseline and in follow up after one and two months.
The expert panel evaluated, and pilot group pre-tested the Time Tracking Form's content validity. The expert panel consisted of seven participants: one head of home care, three home care professionals, and two senior lecturers in nursing with medication management competence, and one statistician. Panel members evaluated each item focusing on usability, but they did not find revision. A pre-test (answers were not included in this study) was performed with 10 home care professionals having the experience using the robot for medication management in older people's home care. This helped evaluate how understandable and clear the Time Tracking Form's content was and how long time it took to be completed.
The SPSS v.26 software was used to analyse data.The characteristics of sample were reported using descriptive statistics including frequencies, percentages, medians, mean values, and standard deviation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kuopio, Finland, 70201
- Riitta Turjamaa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- voluntariness,
- working presently in older people's home care and
- communication in Finnish or English
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention group
In the IG, home care professionals load medications inside the robot, and it enabled older home care clients to carry out medication management by themselves.
|
The effect of a robot in medication management for older people's home care
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Sham Comparator: Control group
In the CG, home care professionals manually dispensed medications to doset and administrating medications during their home visits.
|
The effect of a robot in medication management for older people's home care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline measurement: working time used for medication management during one week
Time Frame: One week
|
Data were collected using the Working Time Tracking Form.
The participants were home care professionals who carried out home care clients' medication management.
Home care clients were allocated into intervention and control groups (n=64 and 46, respectively) based on whether or not they used the robot.
The statistical analysis methods were used.
|
One week
|
Change from baseline working time used for medication management at 1 month during one week
Time Frame: One week
|
Data were collected using the Working Time Tracking Form.
The participants were home care professionals who carried out home care clients' medication management.
Home care clients were allocated into intervention and control groups (n=64 and 46, respectively) based on whether or not they used the robot.
1-month measurement was carried out one month after the baseline measurement.
The aim of the measurement was to evaluate the change of using a robot for medication management on home care professionals' use of working time.
|
One week
|
Change from baseline working time used for medication management at 2 months during one week
Time Frame: One week
|
Data were collected using the Working Time Tracking Form.
The participants were home care professionals who carried out home care clients' medication management.
Home care clients were allocated into intervention and control groups (n=64 and 46, respectively) based on whether or not they used the robot.
2-month measurement was carried out two month after the baseline measurement.
The aim of the measurement was to evaluate the change of using a robot for medication management on home care professionals' use of working time.
|
One week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Riitta Turjamaa, PhD, Savonia University of Applied Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- University of Eastern Finland
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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