NCT03683303

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

September 17, 2018

Last Update Submit

September 24, 2018

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

  • wound care knowledge

    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.

    20 minutes

Secondary Outcomes (8)

  • wound care skills

    30 minutes

  • wound care anxiety

    20 minutes

  • Heart rate variability (HRV)

    10 minutes

  • Blood pressure(BP)

    10 minutes

  • Heart rate (HR)

    10 minutes

  • +3 more secondary outcomes

Study Arms (2)

mobile applications (APP)

EXPERIMENTAL

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).

Behavioral: mobile applications (APP)

oral education

ACTIVE COMPARATOR

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).

Behavioral: oral education

Interventions

mobile applications (APP)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.

mobile applications (APP)
oral educationBEHAVIORAL

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).

oral education

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31814140DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • ya-ping 雅萍 Hou 侯

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 25, 2018

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share