Unrecognized ConditionNCT05908604
Use of a Robot in Medication Management for Older People's Home Care
A study testing Robot for madication management in people with Unrecognized Condition, run by Savonia University of Applied Sciences at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Robot for madication management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFinland
- Study dates
- 30 Aug 2021to 12 Nov 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- voluntariness,
- working presently in older people's home care and
- communication in Finnish or English
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Unrecognized Condition
- Being tested
- Robot for madication management
- Keywords
- home-care professional, medication management, older people's home care, robot, working time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot for madication managementOther
The effect of a robot in medication management for older people's home care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Other: Robot for madication management |
| Control group | Sham comparator | In the CG, home care professionals manually dispensed medications to doset and administrating medications during their home visits. Receives: Other: Robot for madication management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline measurement: working time used for medication management during 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.
Measured: One week
Change from baseline working time used for medication management at 1 month during 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.
Measured: One week
Change from baseline working time used for medication management at 2 months during 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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start30 Aug 2021
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
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 Unrecognized ConditionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savonia University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riitta Turjamaa, Savonia University of Applied Sciences
- Investigators
- Riitta Turjamaa, PhD, Principal investigator, Savonia University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908604
- Sponsor's protocol ID
- University of Eastern Finland
- Status last verified
- Jun 2023
- First submitted
- 6 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kajander-Unkuri S, Vaismoradi M, Katajisto J, Kangasniemi M, Turjamaa R. Effect of robot for medication management on home care professionals' use of working time in older people's home care: a non-randomized controlled clinical trial. BMC Health Serv Res. 2023 Dec 2;23(1):1344. doi: 10.1186/s12913-023-10367-0.
PubMed 38042773
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Robot in Medication Management for Older People's Home Care: a Non-randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05908604
- Acronym / sponsor ID
- University of Eastern Finland
- Conditions
- Unrecognized Condition
- Keywords
- home-care professional, medication management, older people's home care, robot, working time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Savonia University of Applied SciencesUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 18 Jun 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Robot for madication managementIn the IG, home care professionals load medications inside the robot, and it enabled older home care clients to carry out medication management by themselves. |
| Control group | Sham comparator | Other: Robot for madication managementIn the CG, home care professionals manually dispensed medications to doset and administrating medications during their home visits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- voluntariness,
- working presently in older people's home care and
- communication in Finnish or English
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Robot for madication managementThe effect of a robot in medication management for older people's home care | Other | Control group, Intervention group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 38042773Kajander-Unkuri S, Vaismoradi M, Katajisto J, Kangasniemi M, Turjamaa R. Effect of robot for medication management on home care professionals' use of working time in older people's home care: a non-randomized controlled clinical trial. BMC Health Serv Res. 2023 Dec 2;23(1):1344. doi: 10.1186/s12913-023-10367-0.
- Individual participant dataSharing planned: No
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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.
Riitta Turjamaa, PhD principal investigator
Savonia University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot for madication management in people with Unrecognized Condition, run by Savonia University of Applied Sciences at 1 site in Finland.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline measurement: working time used for medication management during one week (time frame: One week). 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 NCT05908604, 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 18 Jun 2023.