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

University of Nicosia

Status: Completed

Conditions: Pressure Ulcer; Telemedicine; Caregivers

Treatments: Device: mHealth App

Study type: Interventional

Funder types: Other

Identifiers

NCT05030935

ΕΕΒΚ/ΕΠ/2021/55

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Intervention Group

Experimental group

Description:

This group will be able to use the mHealth App.

Treatment:

Device: mHealth App

Control group

No Intervention group

Description:

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.