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

Not Applicable

Completed

• Conditions: Caregivers; Pressure Ulcer; Telemedicine
• Interventions: Device: mHealth App

• Registration Number: NCT05030935
• Lead Sponsor: University of Nicosia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-01
• Study Start: 2022-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	mHealth App	This group will be able to use the mHealth App.

Primary Outcome Measures

Name	Time	Method
Pressure Ulcers Prevention Behaviors (PUPB)	4 months	Change from baseline (t1) of PUPB score at 2 months measured (t2) and 4 months measured (t3) for both groups.
FCAT: The Family Caregiver Activation in Transitions®	4 months	Change from baseline score (t1) of FCAT scale at 2 months measured (t2) and 4 months measured (t3) for both groups.

Secondary Outcome Measures

Name	Time	Method
TAM: Technology Acceptance Model	4 months	Change from baseline score (t1) of TAM scale at 2 months measured (t2) and 4 months measured (t3) for intervention group.

Trial Locations

Locations (1)

University of Nicosia; 🇨🇾 Nicosia, Cyprus