The Effects of Educational Program Using APP on Pre-Discharge Knowledge, Skills and Anxiety of Wound Care

NCT ID: NCT03683303

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-31

Brief Summary

The purposes of this study were to understand the effects of mhealth App on wound care knowledge, wound care skills, and anxiety related to dressing change when compared to traditional health education before patients discharged from hospital.

Detailed Description

1. Research design:

This study employed a single-blind experimental design. Study participants were randomized into the experimental and control groups. Participants in the experimental group used the mHealth App as intervention while those in the control group received normal verbal instructions. The levels of wound care knowledge, skills, and anxiety related to dressing change in the two groups were compared before intervention (T1), after intervention (T2), and before discharge (T3).

2. Study setting & samples:

The recruitment site of this study was conducted in a plastic surgery ward at a 1500-bed university hospital located in Southern of Taiwan. Samples were recruited either hospitalized patients or their primary caregivers from March to December 2016. Inclusion criteria were of Taiwanese nationality, were aged 20 years and above, had a wound classification score of 6-10 points according to Strauss (2000), required self-care of wound at home, and had a habit of using smartphones. Exclusion criteria included special care conditions, such as (1) other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures) and (2) being a special patient, such as one with mental illness. Sample estimation based on the F test of MANOVA statistics was carried out using the G Power 3.1 software. Each group had at least 31 samples (effect size = 0.25, ∝ = 0.05, power = 0.85). A total of 76 participants satisfied the inclusion criteria for this study. There were 6 patients who were not willing to participate in this study; therefore, 35 participants were randomized enrolled in each of the experimental and control groups.

Conditions

Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

mobile applications (APP)

A total of 70 participants were randomized to each group for 35 people, the control group receiving the oral patient education and the experimental group receiving patient education using mobile applications. Both groups collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3).

Group Type: EXPERIMENTAL

mobile applications (APP)

Intervention Type: BEHAVIORAL

the experimental group receiving education using Mobile Application (APP), collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3). The SPSS 22.0 for Windows was used for statistics analyses.

oral education

A total of 70 participants were randomized to each group for 35 people, the control group receiving the oral patient education and the experimental group receiving patient education using mobile applications. Both groups collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3).

Group Type: ACTIVE_COMPARATOR

oral education

Intervention Type: BEHAVIORAL

the control group receiving the oral education, collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3).

Interventions

mobile applications (APP)

the experimental group receiving education using Mobile Application (APP), collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3). The SPSS 22.0 for Windows was used for statistics analyses.

Intervention Type: BEHAVIORAL

oral education

the control group receiving the oral education, collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• aged 20 years and above.
• wound classification score of 6-10 points according to Strauss (2000).
• required wound self-care at home or care by their primary caregivers.
• had a habit of using smartphones.

Exclusion Criteria

• other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures).
• being a special patient, such as one with mental illness.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ya-ping 雅萍 Hou 侯

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

References

Chang HY, Hou YP, Yeh FH, Lee SS. The impact of an mHealth app on knowledge, skills and anxiety about dressing changes: A randomized controlled trial. J Adv Nurs. 2020 Apr;76(4):1046-1056. doi: 10.1111/jan.14287. Epub 2019 Dec 20.

Reference Type: DERIVED

PMID: 31814140 (View on PubMed)

Other Identifiers

KMUHIRB-E(II)-20160030

Identifier Type: -

Identifier Source: org_study_id