Clinical trial NCT03683303: The Effects of Educational Program Using APP on Pre-Discharge Knowledge, Skills and Anxiety of Wound Care
Official title: The Mobile Applications (APP) for Patient Education Has Promoted the Knowledge, Skills on the Wound Care and Reduced the Anxiety of Wound Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: wound care knowledge
timeFrame: 20 minutes
Secondary outcomes:
measure: wound care skills
timeFrame: 30 minutes
measure: wound care anxiety
timeFrame: 20 minutes
measure: Heart rate variability (HRV)
timeFrame: 10 minutes
measure: Blood pressure(BP)
timeFrame: 10 minutes
measure: Heart rate (HR)
timeFrame: 10 minutes
measure: High frequency power (HF)
timeFrame: 10 minutes
measure: Low frequency power (LF)
timeFrame: 10 minutes
measure: The ratio of LF/HF
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: ya-ping 雅萍 Hou 侯
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.