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Clinical Trials/NCT03683303
NCT03683303CompletedNot Applicable

The Mobile Applications (APP) for Patient Education Has Promoted the Knowledge, Skills on the Wound Care and Reduced the Anxiety of Wound Care

Kaohsiung Medical University Chung-Ho Memorial Hospital0 sites70 target enrollmentStarted: March 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Primary Endpoint
wound care knowledge

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

wound care knowledge

Time Frame: 20 minutes

wound care knowledge scale was designed by Li (2008) and was used in the studies of Shao (2013) and Liu (2016). The content validity index (CVI) of this 20-item scale was 1.00 for its feasibility, 0.94 for its definiteness and 0.98 for its Appropriateness. A higher score indicates the higher level of wound care knowledge.

Secondary Outcomes

  • wound care anxiety(20 minutes)
  • High frequency power (HF)(10 minutes)
  • wound care skills(30 minutes)
  • Heart rate (HR)(10 minutes)
  • Low frequency power (LF)(10 minutes)
  • Heart rate variability (HRV)(10 minutes)
  • The ratio of LF/HF(10 minutes)
  • Blood pressure(BP)(10 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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