ClinicalTrials.gg
CompletedNCT05030935Updated Jun 26, 2023

Assessing the Feasibility of a Prevention m-Health App Intervention for Informal Caregivers of Outpatients

An interventional study of mHealth App in Telemedicine, Caregivers and Pressure Ulcer, sponsored by University of Nicosia. Completed at 1 site in Cyprus. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-06-26.

Sponsored by University of Nicosia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Telemedicine
  • Caregivers
  • Pressure Ulcer

Browse trials for

Keywords

  • Pressure Ulcer Prevention, mHealth, quasi-experimental
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's enrollment of 45 is below the median of 70 across 405 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

University of Nicosia is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Intervention Group

    This group will be able to use the mHealth App.

    Device: mHealth App

  • No intervention
    Control group

    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.

Interventions

  • DevicemHealth App

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 months

  2. 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.

    Time frame: 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.

    Time frame: 4 months

07

Study locations

1 site
  • University of Nicosia
    Nicosia, 2417, Cyprus
08

References and documents

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.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05030935
Lead sponsor
University of Nicosia
Responsible party
Giannis Polychronis (Doctoral Candidate, University of Nicosia) — Principal investigator
First posted
Sep 1, 2021
Start date
Jan 1, 2022
Primary completion
Jan 1, 2023
Completion
Jan 1, 2023
Last update
Jun 26, 2023

Study contacts

Zoe Roupa, PhD
study director · University of Nicosia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion