Clinical trial NCT05030935: Assessing the Feasibility of a Prevention m-Health App Intervention for Informal Caregivers of Outpatients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Caregivers
Pressure Ulcer
Keywords: Pressure Ulcer Prevention, mHealth, quasi-experimental
Lead sponsor: University of Nicosia
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: FCAT: The Family Caregiver Activation in Transitions®
timeFrame: 4 months
measure: Pressure Ulcers Prevention Behaviors (PUPB)
timeFrame: 4 months
Secondary outcomes:
measure: TAM: Technology Acceptance Model
timeFrame: 4 months
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: University of Nicosia
Study officials:
affiliation: University of Nicosia
name: Zoe Roupa, PhD
role: STUDY_DIRECTOR
References:
citation: 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.