Back to resultsAssessing the Feasibility of a Prevention m-Health App Intervention for Informal Caregivers of Outpatients
Primary Purpose
Telemedicine, Caregivers, Pressure Ulcer
Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
mHealth App
Sponsored by
About this trial
This is an interventional prevention trial for Telemedicine focused on measuring Pressure Ulcer Prevention, mHealth, quasi-experimental
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 (≤ 14).
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).
Sites / Locations
- University of Nicosia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control group
Arm Description
This group will be able to use the mHealth App.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05030935
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nicosia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Caregivers, Pressure Ulcer
Keywords
Pressure Ulcer Prevention, mHealth, quasi-experimental
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
This group will be able to use the mHealth App.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
mHealth App
Intervention Description
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.
Primary Outcome Measure Information:
Title
FCAT: The Family Caregiver Activation in Transitions®
Description
Change from baseline score (t1) of FCAT scale at 2 months measured (t2) and 4 months measured (t3) for both groups.
Time Frame
4 months
Title
Pressure Ulcers Prevention Behaviors (PUPB)
Description
Change from baseline (t1) of PUPB score at 2 months measured (t2) and 4 months measured (t3) for both groups.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
TAM: Technology Acceptance Model
Description
Change from baseline score (t1) of TAM scale at 2 months measured (t2) and 4 months measured (t3) for intervention group.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoe Roupa, PhD
Organizational Affiliation
University of Nicosia
Official's Role
Study Director
Facility Information:
Facility Name
University of Nicosia
City
Nicosia
ZIP/Postal Code
2417
Country
Cyprus
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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.
Results Reference
background
Learn more about this trial
Assessing the Feasibility of a Prevention m-Health App Intervention for Informal Caregivers of Outpatients
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