WoundNCT03683303
The Effects of Educational Program Using APP on Pre-Discharge Knowledge, Skills and Anxiety of Wound Care
A study testing mobile applications (APP) and oral education in people with Wound, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Wound
- What is being tested?
- mobile applications (APP) and oral education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures).
- being a special patient, such as one with mental illness.
About this study
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
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.
Read the detailed description
- 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).
- 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
- Being tested
- mobile applications (APP), oral education
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile applications (APP)Behavioural
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 educationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: oral education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (8)
wound care skills
wound care skills scale was designed by Chen (2010) with 11 items. The CVI for each item was between 0.8 and 1.0 with good validity. The internal consistency reliability of this scale (Cronbach's α) was 0.87. A higher score indicates the higher level of wound care skills. This scale was assessed by healthcare professionals when patients or their caregivers performed wound dressing change.
Measured: 30 minutes
wound care anxiety
State-Trait Anxiety Inventory (STAI) was designed by Spielberger, Gorsuch, \& Lushene (1970) with 20 items for assessing trait anxiety and 20 for state anxiety. The internal consistency reliability for the scale have ranged from .86 to .95 and test-retest reliability have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983). The revised Chinese version of the STAI scale was 0.9 for situation-specific anxiety and 0.86 for trait anxiety (Chung \& Lung, 1984). A higher score indicates the higher level of wound care anxiety.
Measured: 20 minutes
Heart rate variability (HRV)
Heart rate variability (HRV) was measured by the ANS Watch (Department of Health Medical Device Permit Numbers: 001525) to record the variation in the time interval between heartbeats. It can indicate the levels of anxiety from the inputs of the sympathetic and the parasympathetic nervous system and humoral factors. When the level of anxiety is high, patients' physiological effects decreasing in HRV(Huang, Lin, Huang, \&Hung, 2008).
Measured: 10 minutes
Blood pressure(BP)
Both systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured by the ANS Watch (Department of Health Medical Device Permit Numbers: 001525) to record the variation in the time interval between blood pressure. It can indicate the levels of anxiety from the inputs of the sympathetic and the parasympathetic nervous system and humoral factors. When the level of anxiety is high, patients' physiological effects increase in systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Huang, Lin, Huang, \&Hung, 2008).
Measured: 10 minutes
Heart rate (HR)
Heart rate was measured by the ANS Watch (Department of Health Medical Device Permit Numbers: 001525) to record the variation in the time interval between heartbeats. It can indicate the levels of anxiety from the inputs of the sympathetic and the parasympathetic nervous system and humoral factors. When the level of anxiety is high, patients' physiological effects increase in heart rate(Huang, Lin, Huang, \&Hung, 2008).
Measured: 10 minutes
High frequency power (HF)
High frequency power (HF) was measured by the ANS Watch (Department of Health Medical Device Permit Numbers: 001525) to record the variation in the time interval between heartbeats. It can indicate the levels of anxiety from the inputs of the sympathetic and the parasympathetic nervous system and humoral factors. When the level of anxiety is high, patients' physiological effects decreasing in HF(Huang, Lin, Huang, \&Hung, 2008).
Measured: 10 minutes
Low frequency power (LF)
Low frequency power (LF) was measured by the ANS Watch (Department of Health Medical Device Permit Numbers: 001525) to record the variation in the time interval between heartbeats. It can indicate the levels of anxiety from the inputs of the sympathetic and the parasympathetic nervous system and humoral factors. When the level of anxiety is high, patients' physiological effects increase in LF(Huang, Lin, Huang, \&Hung, 2008).
Measured: 10 minutes
The ratio of LF/HF
Heart rate variability was measured by the ANS Watch (Department of Health Medical Device Permit Numbers: 001525) to record the variation in the time interval between heartbeats. It can indicate the levels of anxiety from the inputs of the sympathetic and the parasympathetic nervous system and humoral factors. When the level of anxiety is high, patients' physiological effects increase in ratio of LF/HF(Huang, Lin, Huang, \&Hung, 2008).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ya-ping 雅萍 Hou 侯, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683303
- Sponsor's protocol ID
- KMUHIRB-E(II)-20160030
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31814140
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03683303
- Acronym / sponsor ID
- KMUHIRB-E(II)-20160030
- Conditions
- Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile applications (APP) | Experimental | Behavioral: 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). |
| oral education | Active comparator | Behavioral: oral educationA 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures).
- being a special patient, such as one with mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | mobile applications (APP) |
| oral educationthe 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). | Behavioural | oral education |
Primary outcome
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.
8 secondary outcomes
wound care skills
Time frame: 30 minutes
wound care anxiety
Time frame: 20 minutes
Heart rate variability (HRV)
Time frame: 10 minutes
Blood pressure(BP)
Time frame: 10 minutes
Heart rate (HR)
Time frame: 10 minutes
High frequency power (HF)
Time frame: 10 minutes
Low frequency power (LF)
Time frame: 10 minutes
The ratio of LF/HF
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Derived from this study: PubMed 31814140Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ya-ping 雅萍 Hou 侯 principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing mobile applications (APP) and oral education in people with Wound, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound care knowledge (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.