BurnsNCT06263296
Smartphone Assisted Self-management Education for Adult Burn Patient At Aftercare
A study testing Self Management Education in people with Burns and Self Efficacy, run by Queen Mary Hospital, Hong Kong at 1 site in China.
Trial summary
Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Self Efficacy, Burn Second Degree
- What is being tested?
- Self Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2024to 30 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese adult aged above 18 years old
- Hospitalized burn patient
- Adult who can understand Cantonese
- Superficial partial thickness burn: TBSA >10%
- Deep partial thickness burn or full thickness burn: TBSA > 5%
Who cannot join
- Inhalation injury solely
- Sustained burn injury due to self-injury
- Diagnosed psychiatric illness with or without medication
- Client who is unable to communicate via instant messaging apps
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
LIU Siu Kwong
Hong Kong
Siu Kwong LIU, ANC, 852 22557610, onceliu@yahoo.com.hk
About this study
Official title: The Impact on Quality of Life in Individual with Burn Injury: Utilizing Smartphone Assisted Self-management Education At Aftercare
Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population
There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.
Read more
The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:
- Higher level of health-related quality of life,
- Higher level of self-efficacy
- Higher level of score in Burn Rehabilitation Knowledge
- Lower pain level, as measured by Numeric Pain Rating Scale; and
- Lower level of itchiness
The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.
For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required.
Read the detailed description
Due to the advancement of medical treatment, burn-related mortality has been reduced especially in developed countries . Long-term undesirable impacts such as wound problems, skin care, exercise training, scar management, psychological and social problems have been detected in both major and non-major burns (less than 20% total body surface area (TBSA). The focus of burn care is shifted not only acute care but also rehabilitation.
Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population
There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.
The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:
- Higher level of health-related quality of life,
- Higher level of self-efficacy
- Higher level of score in Burn Rehabilitation Knowledge
- Lower pain level, as measured by Numeric Pain Rating Scale; and
- Lower level of itchiness
The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period.
Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care.
After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.
For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning.
Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge.
After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required.
- Conditions
- Burns, Self Efficacy, Burn Second Degree, Burns Third Degree, Quality of Life, Adherence, Treatment
- Being tested
- Self Management Education
- Medical subject headings
- Burns, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Management EducationBehavioural
Smartphone assisted self management education incorporated with the concept of motivational interviewing
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Receives: Behavioral: Self Management Education |
| Control Group | No intervention | For control group, participants will receive usual care by ward nurses (provide burn discharge pamphlet upon discharge + regular plastic surgeon follow up) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12
Burn Specific Health Scale-Brief (BSHS-B) Taiwanese version (40-items, Appendix 7) will be used to quantify the recovery of quality of life (QoL) among burn survivor in general, physical, mental, and social health aspects. Responses are measured on a 5-point scale ranging from 0 ("extreme") to 4 ("none at all"). The total (BSHS-B score is the sum of the subscale scores (range: 0-160), with a higher score indicating better quality of life post burn injury.
Measured: Baseline and Week 4; Week 12
Change from Baseline in the Generic Quality of life at Week 4 & Week 12
5Q-5D-5L Hong Kong- Traditional Chinese version (Appendix 8) ls used to measure the generic health-related quality of life (HRQoL) among subjects. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state.
Measured: Baseline and Week 4; Week 12
Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire
The Burn Rehabilitation Knowledge Questionnaire is developed by the principal investigator after reviewing the relevant and recent international scientific literature to identify patients' learning needs and essential concept in facilitating burn rehabilitation. This questionnaire consisted of twenty-four multiple choice questions covering three well-defined areas: general knowledge about burns (8 items), rehabilitation modalities (8 items), and burns related healthy lifestyle modifications (8 items). The total scores were computed out of (24 grades). A higher score indicated better knowledge in burn rehabilitation.
Measured: Baseline and Week 4
Secondary outcomes (3)
Change from Baseline in the Self efficacy at Week 4 & Week 12
Chinese Adaptation of the General Self-Efficacy Scale (C-GSE, 10 items, Appendix 9) will be used to measure the sense of self efficacy of the patients. The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety. Responses are measured on a 4-point scale ranging from 1 ("Not at all") to 4 ("Exactly True"). The total GSE score is the sum of the subscale scores (range: 10-40), with a higher score indicating more self-efficacy.
Measured: Baseline and Week 4; Week 12
Change from Baseline in the Itchiness of life at Week 4 & Week 12
5D itch score(5D-IS)- Chinese version (Appendix 10) will be used to measure severity of itchiness in five dimensions which are degree, duration, direction, disability and distribution. the first four domains were measured on a five-point Likert scale. The distribution domain included 16 potential locations of itch, the more itchy area, the higher score will be obtained in this domain. Responses are measured on a 5-point scale ranging from 1 to 5 ranged between 5 (no pruritus) and 25 (most severe pruritus).
Measured: Baseline and Week 4; Week 12
Change from Baseline in the Pain level at Week 4 & Week 12
Numeric Pain Rating Scale (NPRS) will be used to measure the subjective intensity of pain. Responses are measured on a 11-point scale ranging from 0 ("no pain") to 10 ("the most intense pain imaginable").
Measured: Baseline and Week 4; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start10 Feb 2024
- Primary completion28 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Siu Kwong, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263296
- Sponsor's protocol ID
- UW 24-055
- Status last verified
- May 2024
- First submitted
- 8 Feb 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Procter F. Rehabilitation of the burn patient. Indian J Plast Surg. 2010 Sep;43(Suppl):S101-13. doi: 10.4103/0970-0358.70730.
PubMed 21321643Spronk I, Legemate C, Oen I, van Loey N, Polinder S, van Baar M. Health related quality of life in adults after burn injuries: A systematic review. PLoS One. 2018 May 24;13(5):e0197507. doi: 10.1371/journal.pone.0197507. eCollection 2018.
PubMed 29795616Esselman PC. Burn rehabilitation: an overview. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S3-6. doi: 10.1016/j.apmr.2007.09.020.
PubMed 18036978Smolle C, Cambiaso-Daniel J, Forbes AA, Wurzer P, Hundeshagen G, Branski LK, Huss F, Kamolz LP. Recent trends in burn epidemiology worldwide: A systematic review. Burns. 2017 Mar;43(2):249-257. doi: 10.1016/j.burns.2016.08.013. Epub 2016 Sep 3.
PubMed 27600982Barrett LW, Fear VS, Waithman JC, Wood FM, Fear MW. Understanding acute burn injury as a chronic disease. Burns Trauma. 2019 Sep 16;7:23. doi: 10.1186/s41038-019-0163-2. eCollection 2019.
PubMed 31534977
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Quality of Life in Individual with Burn Injury: Utilizing Smartphone Assisted Self-management Education At Aftercare
- ClinicalTrials.gov ID
- NCT06263296
- Acronym / sponsor ID
- UW 24-055
- Conditions
- Burns, Self Efficacy, Burn Second Degree, Burns Third Degree, Quality of Life, Adherence, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Feb 2024 (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.
Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population
There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.
The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:
- Higher level of health-related quality of life,
- Higher level of self-efficacy
- Higher level of score in Burn Rehabilitation Knowledge
- Lower pain level, as measured by Numeric Pain Rating Scale; and
- Lower level of itchiness
The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.
For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required.
Detailed description
Due to the advancement of medical treatment, burn-related mortality has been reduced especially in developed countries . Long-term undesirable impacts such as wound problems, skin care, exercise training, scar management, psychological and social problems have been detected in both major and non-major burns (less than 20% total body surface area (TBSA). The focus of burn care is shifted not only acute care but also rehabilitation.
Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population
There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.
The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:
- Higher level of health-related quality of life,
- Higher level of self-efficacy
- Higher level of score in Burn Rehabilitation Knowledge
- Lower pain level, as measured by Numeric Pain Rating Scale; and
- Lower level of itchiness
The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period.
Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care.
After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.
For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning.
Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge.
After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pilot Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Self Management EducationFor intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. |
| Control Group | No intervention | –For control group, participants will receive usual care by ward nurses (provide burn discharge pamphlet upon discharge + regular plastic surgeon follow up) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese adult aged above 18 years old
- Hospitalized burn patient
- Adult who can understand Cantonese
- Superficial partial thickness burn: TBSA >10%
- Deep partial thickness burn or full thickness burn: TBSA > 5%
Key exclusion criteria (4 listed)
- Inhalation injury solely
- Sustained burn injury due to self-injury
- Diagnosed psychiatric illness with or without medication
- Client who is unable to communicate via instant messaging apps
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 |
|---|---|---|
| Self Management EducationSmartphone assisted self management education incorporated with the concept of motivational interviewing | Behavioural | Interventional Group |
Primary outcome
Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12
Time frame: Baseline and Week 4; Week 12
Burn Specific Health Scale-Brief (BSHS-B) Taiwanese version (40-items, Appendix 7) will be used to quantify the recovery of quality of life (QoL) among burn survivor in general, physical, mental, and social health aspects. Responses are measured on a 5-point scale ranging from 0 ("extreme") to 4 ("none at all"). The total (BSHS-B score is the sum of the subscale scores (range: 0-160), with a higher score indicating better quality of life post burn injury.
Change from Baseline in the Generic Quality of life at Week 4 & Week 12
Time frame: Baseline and Week 4; Week 12
5Q-5D-5L Hong Kong- Traditional Chinese version (Appendix 8) ls used to measure the generic health-related quality of life (HRQoL) among subjects. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state.
Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire
Time frame: Baseline and Week 4
The Burn Rehabilitation Knowledge Questionnaire is developed by the principal investigator after reviewing the relevant and recent international scientific literature to identify patients' learning needs and essential concept in facilitating burn rehabilitation. This questionnaire consisted of twenty-four multiple choice questions covering three well-defined areas: general knowledge about burns (8 items), rehabilitation modalities (8 items), and burns related healthy lifestyle modifications (8 items). The total scores were computed out of (24 grades). A higher score indicated better knowledge in burn rehabilitation.
3 secondary outcomes
Change from Baseline in the Self efficacy at Week 4 & Week 12
Time frame: Baseline and Week 4; Week 12
Change from Baseline in the Itchiness of life at Week 4 & Week 12
Time frame: Baseline and Week 4; Week 12
Change from Baseline in the Pain level at Week 4 & Week 12
Time frame: Baseline and Week 4; Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 21321643Procter F. Rehabilitation of the burn patient. Indian J Plast Surg. 2010 Sep;43(Suppl):S101-13. doi: 10.4103/0970-0358.70730.
- Background: PubMed 29795616Spronk I, Legemate C, Oen I, van Loey N, Polinder S, van Baar M. Health related quality of life in adults after burn injuries: A systematic review. PLoS One. 2018 May 24;13(5):e0197507. doi: 10.1371/journal.pone.0197507. eCollection 2018.
- Background: PubMed 18036978Esselman PC. Burn rehabilitation: an overview. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S3-6. doi: 10.1016/j.apmr.2007.09.020.
- Background: PubMed 27600982Smolle C, Cambiaso-Daniel J, Forbes AA, Wurzer P, Hundeshagen G, Branski LK, Huss F, Kamolz LP. Recent trends in burn epidemiology worldwide: A systematic review. Burns. 2017 Mar;43(2):249-257. doi: 10.1016/j.burns.2016.08.013. Epub 2016 Sep 3.
- Background: PubMed 31534977Barrett LW, Fear VS, Waithman JC, Wood FM, Fear MW. Understanding acute burn injury as a chronic disease. Burns Trauma. 2019 Sep 16;7:23. doi: 10.1186/s41038-019-0163-2. eCollection 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Management Education in people with Burns and Self Efficacy, run by Queen Mary Hospital, Hong Kong at 1 site in China.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12 (time frame: Baseline and Week 4; Week 12). The study lists 3 primary outcomes in all. 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 NCT06263296, which also lists 5 linked publications.
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 17 Oct 2024.