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

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 Overview

• Status: Completed
• Conditions: Telemedicine; Pressure Ulcer; Caregivers
• Intervention / Treatment: Device: mHealth App

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giannis Polychronis, PhD(c); Phone Number: +35796206593; Email: polychronis.y@live.unic.ac.cy
• Study Contact Backup: Name: Theodoros Millidonis; Phone Number: +35722841785; Email: millidonis.t@unic.ac.cy

Study Locations

• Cyprus
  • Nicosia, Cyprus, 2417
    • University of Nicosia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; This group will be able to use the mHealth App.	Device: mHealth 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Collaborators and Investigators

• Sponsor: University of Nicosia
• Investigators: Study Director: Zoe Roupa, PhD, University of Nicosia

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pressure Ulcer Prevention, mHealth, quasi-experimental
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: ΕΕΒΚ/ΕΠ/2021/55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No