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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030935
• Other study ID #: ????/??/2021/55
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2023
• Source: University of Nicosia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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).

Related Conditions & MeSH terms

• Caregivers
• Pressure Ulcer
• Telemedicine
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Cyprus	University of Nicosia	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
University of Nicosia

Country where clinical trial is conducted

Cyprus, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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