Use of a Robot in Medication Management for Older People's Home Care

June 10, 2023 updated by: Riitta Turjamaa, Savonia University of Applied Sciences

The Effect of a Robot in Medication Management for Older People's Home Care: a Non-randomized Controlled Clinical Trial

Non-randomized controlled clinical trial was used. Data were collected using the Working Time Tracking Form in three data collection points (baseline, at 1 month and at 2 month). 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70201
        • Riitta Turjamaa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • voluntariness,
  • working presently in older people's home care and
  • communication in Finnish or English

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Robot for madication management
The effect of a robot in medication management for older people's home care
Sham Comparator: Control group
In the CG, home care professionals manually dispensed medications to doset and administrating medications during their home visits.
Other: Robot for madication management
The effect of a robot in medication management for older people's home care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Savonia University of Applied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Riitta Turjamaa, PhD, Savonia University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • University of Eastern Finland

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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