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

NCT05030935 | Completed

• 1 other identifier: ΕΕΒΚ/ΕΠ/2021/55
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Telemedicine; Caregivers; Pressure Ulcer

Keywords

Pressure Ulcer Prevention, mHealth, quasi-experimental

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• TAM: Technology Acceptance Model

  4 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group will be able to use the mHealth App.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nicosia: lead

Study Sites (1)

University of Nicosia

Nicosia, 2417, Cyprus

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zoe Roupa, PhD

  University of Nicosia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 1, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)