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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05030935
Enrollment
45
Registered
2021-09-01
Start date
2022-01-01
Completion date
2023-01-01
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers, Pressure Ulcer, Telemedicine

Keywords

Pressure Ulcer Prevention, mHealth, quasi-experimental

Brief 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.

Interventions

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.

Sponsors

University of Nicosia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No

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

* 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).

Design outcomes

Primary

MeasureTime frameDescription
FCAT: The Family Caregiver Activation in Transitions®4 monthsChange 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)4 monthsChange from baseline (t1) of PUPB score at 2 months measured (t2) and 4 months measured (t3) for both groups.

Secondary

MeasureTime frameDescription
TAM: Technology Acceptance Model4 monthsChange from baseline score (t1) of TAM scale at 2 months measured (t2) and 4 months measured (t3) for intervention group.

Countries

Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026