TelemedicineNCT05030935
Assessing the Feasibility of a Prevention m-Health App Intervention for Informal Caregivers of Outpatients
A study testing mHealth App in people with Telemedicine and Caregivers, run by University of Nicosia at 1 site in Cyprus.
Trial summary
The present quasi-experimental study aims to compare the level of preventive behaviours amongst caregivers who will be instructed to operating one mHealth App or given a relevant instruction manual. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Telemedicine, Caregivers, Pressure Ulcer
- What is being tested?
- mHealth App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jan 2022to 1 Jan 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main adult caregiver is able to provide care / support to a bedridden patient.
- Willingness to participate in the study.
- Basic knowledge of the Greek language such that the user can understand the intervention and be able to complete the self-administered questionnaire.
- Possession of a mobile Android or iOS device.
- The patient is bedridden for no longer than four (4) months.
- During the assessment for predicting the risk of patient PUs development, the score according to the BRADEN scale must be between medium to severe risk (≤ 18).
Who cannot join
- The user does not have basic knowledge of the Greek language such that he/she is not able to understand the intervention or complete the self-administered questionnaire.
- Possession of a different mobile device other than Android and iOS or no possession of a mobile device.
- The patient is bedridden for four (4) months or longer.
- A mild risk score using the BRADEN scale (15-18).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility of a Novel Preventive Mobile Health App Among Informal Caregivers of Outpatients at Risk of Developing Pressure Ulcers: A Quasi-Experimental Study
The present quasi-experimental study aims to compare the level of preventive behaviours amongst caregivers who will be instructed to operating one mHealth App or given a relevant instruction manual. To achieve this, a comparison between the behavior of caregivers before and after the intervention and a comparison between the two groups (intervention group with the control group) will be performed. Specifically, data within the two groups will be collected via an online questionnaire consisting of three parts: prior to the intervention (baseline), two (2) and four (4) months after the intervention. The self-administered questionnaire consists of fifty-two (52) questions and uses three valid and reliable scales with a part that was developed via a bibliography research and consultations from experienced specialists. The questionnaire scales have been translated from the English language to Greek.
- Conditions
- Telemedicine, Caregivers, Pressure Ulcer
- Being tested
- mHealth App
- Keywords
- Pressure Ulcer Prevention, mHealth, quasi-experimental
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth AppDevice
In short, mHA contains three main functions for the user: a) a reminder for switching the patient position, b) training for preventive care habits and c) the possibility for patient evaluation in order to determine the need for the use of support surfaces.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will be able to use the mHealth App. Receives: Device: mHealth App |
| Control group | No intervention | The Instructions Manual consists of a hard copy of the mHealth App bibliographical content. In addition, a calendar that can be used as a reminder for patient position switching is present and a hard copy explanation of the scale which can be used by the caregiver and through handwriting, determine the need for support surfaces. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FCAT: The Family Caregiver Activation in Transitions®
Change from baseline score (t1) of FCAT scale at 2 months measured (t2) and 4 months measured (t3) for both groups.
Measured: 4 months
Pressure Ulcers Prevention Behaviors (PUPB)
Change from baseline (t1) of PUPB score at 2 months measured (t2) and 4 months measured (t3) for both groups.
Measured: 4 months
Secondary outcomes (1)
TAM: Technology Acceptance Model
Change from baseline score (t1) of TAM scale at 2 months measured (t2) and 4 months measured (t3) for intervention group.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
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 TelemedicineStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nicosia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giannis Polychronis, University of Nicosia
- Investigators
- Zoe Roupa, PhD, Study director, University of Nicosia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030935
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2021/55
- Status last verified
- Jun 2023
- First submitted
- 22 Aug 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polychronis, G. et al. (2022) "A Pressure Ulcer Prevention mHealth App for Informal Caregivers of Bedridden Outpatients: Validation," Cyprus Nursing Chronicles, 22(2), pp. 9-18.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of a Novel Preventive Mobile Health App Among Informal Caregivers of Outpatients at Risk of Developing Pressure Ulcers: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT05030935
- Acronym / sponsor ID
- ΕΕΒΚ/ΕΠ/2021/55
- Conditions
- Telemedicine, Caregivers, Pressure Ulcer
- Keywords
- Pressure Ulcer Prevention, mHealth, quasi-experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of NicosiaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 1 Sep 2021 (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.
The present quasi-experimental study aims to compare the level of preventive behaviours amongst caregivers who will be instructed to operating one mHealth App or given a relevant instruction manual. To achieve this, a comparison between the behavior of caregivers before and after the intervention and a comparison between the two groups (intervention group with the control group) will be performed. Specifically, data within the two groups will be collected via an online questionnaire consisting of three parts: prior to the intervention (baseline), two (2) and four (4) months after the intervention. The self-administered questionnaire consists of fifty-two (52) questions and uses three valid and reliable scales with a part that was developed via a bibliography research and consultations from experienced specialists. The questionnaire scales have been translated from the English language to Greek.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: mHealth AppThis group will be able to use the mHealth App. |
| Control group | No intervention | –The Instructions Manual consists of a hard copy of the mHealth App bibliographical content. In addition, a calendar that can be used as a reminder for patient position switching is present and a hard copy explanation of the scale which can be used by the caregiver and through handwriting, determine the need for support surfaces. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The main adult caregiver is able to provide care / support to a bedridden patient.
- Willingness to participate in the study.
- Basic knowledge of the Greek language such that the user can understand the intervention and be able to complete the self-administered questionnaire.
- Possession of a mobile Android or iOS device.
- The patient is bedridden for no longer than four (4) months.
Key exclusion criteria (4 listed)
- The user does not have basic knowledge of the Greek language such that he/she is not able to understand the intervention or complete the self-administered questionnaire.
- Possession of a different mobile device other than Android and iOS or no possession of a mobile device.
- The patient is bedridden for four (4) months or longer.
- A mild risk score using the BRADEN scale (15-18).
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 |
|---|---|---|
| mHealth AppIn short, mHA contains three main functions for the user: a) a reminder for switching the patient position, b) training for preventive care habits and c) the possibility for patient evaluation in order to determine the need for the use of support surfaces. | Device | Intervention Group |
Primary outcome
FCAT: The Family Caregiver Activation in Transitions®
Time frame: 4 months
Change from baseline score (t1) of FCAT scale at 2 months measured (t2) and 4 months measured (t3) for both groups.
Pressure Ulcers Prevention Behaviors (PUPB)
Time frame: 4 months
Change from baseline (t1) of PUPB score at 2 months measured (t2) and 4 months measured (t3) for both groups.
1 secondary outcome
TAM: Technology Acceptance Model
Time frame: 4 months
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 26 Jun 2023.
- BackgroundPolychronis, G. et al. (2022) "A Pressure Ulcer Prevention mHealth App for Informal Caregivers of Bedridden Outpatients: Validation," Cyprus Nursing Chronicles, 22(2), pp. 9-18.
- 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.
Zoe Roupa, PhD study director
University of Nicosia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth App in people with Telemedicine and Caregivers, run by University of Nicosia at 1 site in Cyprus.
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 6 inclusion and 4 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 26 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 Cyprus. 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?
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?
FCAT: The Family Caregiver Activation in Transitions® (time frame: 4 months). The study lists 2 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 NCT05030935, 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 26 Jun 2023.