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

NCT ID: NCT05030935

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-01-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

This group will be able to use the mHealth App.

Group Type: EXPERIMENTAL

mHealth App

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nicosia

OTHER

Sponsor Role: lead

Responsible Party

Giannis Polychronis

Doctoral Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zoe Roupa, PhD

Role: STUDY_DIRECTOR

University of Nicosia

Locations

University of Nicosia

Nicosia, , Cyprus

Countries

Cyprus

References

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.

Reference Type: BACKGROUND

Other Identifiers

ΕΕΒΚ/ΕΠ/2021/55

Identifier Type: -

Identifier Source: org_study_id