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Completed

NCT Number: NCT05030935

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

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.

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Key information

Conditions

Telemedicine Caregivers Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nicosia

Nicosia, 2417, Cyprus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

mHealth app

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. TAM: Technology Acceptance Model

    Time frame: 4 months

    Change from baseline score (t1) of TAM scale at 2 months measured (t2) and 4 months measured (t3) for intervention group.

Sponsors and collaborators

Lead sponsor

University of Nicosia

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2021
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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