BurnsBETNCT06782126

A Study Protocol for the Implementation and Evaluation of a Self-management Support Program in Burns Aftercare for Burn Survivors in the Netherlands

An observational study of Burns, run by Martini Hospital Groningen at 3 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Burns
What is being tested?: BreeZe (Brandwonden en Zelfmanagement)
Type of treatment: Lifestyle or therapy programme
How many people: 146 participants
Where: 3 sitesNetherlands
Study dates: 15 Apr 2024to 14 Jul 2026
Phase: Observational
Are there results?: Not yet: the study is under way

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

Study population: The Emergency Management of Severe Burns (EMSB) referral criteria guide the decision to refer burn patients to a specialized burn center. Criteria for referral include: 1) total burned body surface area (TBSA) >10%, 2) >5% full-thickness burns, 3) circular burns around the neck, thorax, or extremities, 4) burns around functional areas, 5) burns with other trauma, 6) chemical burns, 7) pre-existing diseases, or 8) electrical burns. Minor burns may be managed in tertiary trauma centers or non-burn facilities, but most burn survivors are either directly admitted or transferred to a burn center. In the Netherlands, approximately 800 burn survivors are admitted to one of the three designated burn centers annually. These centers meet specific criteria for expertise, facilities, and quality of care to provide optimal treatment for burn patients.

Who may be able to join

18 years or older
Admission in one of the burn centers > 24 hours and/or debridement or skin graft operation
Proficiency of the Dutch language

Who cannot join

Acute psychiatric illness
Cognitive limitations
Discharge to a different healthcare institution

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

Red Cross Hospital Beverwijk
Beverwijk, North Holland, 1942LE
Burn Center Martini Hospital
Groningen, 9728NT
Maasstad Hospital Rotterdam
Rotterdam, South Holland, 3079DZ

Other trials in Netherlands

About this study

Official title: Self-management Support After Burns: Study Protocol for a Multicenter Stepped-wedge Hybrid Type 2 Effectiveness-implementation Study

This study aims to evaluate a new self-management support intervention for burn survivors called BreeZe. The overall goal of BreeZe is to enhance burn survivors' self-management skills in order to integrate treatment and life goals and subsequently optimize burn survivors' quality of life and health-related outcomes. The BreeZe intervention is based on the content of the ZENN intervention, an evidence-based self-management support intervention for transplant recipient patients, which we adapted to the context of burn care. The BreeZe intervention is based on the theoretical framework of the Self-Regulation Theory. The main intervention strategies are based on evidence-based techniques, namely goal setting and pursuit, Solution-Focused Brief-Therapy, and Motivational Interviewing. In practice, this means that the intervention focuses on a positive approach in order to enhance burn survivors' intrinsic motivation and self-efficacy to encourage sustainable behaviour change regarding self-management in burns aftercare. To achieve this, we will implement BreeZe using various implementation strategies. These will include educating healthcare professionals on self-management, training them in communication skills (e.g. motivational interviewing), and providing supportive materials such as a decision aid tool (i.e., self-management web) and a workbook tailored for burn survivors.

This multicenter stepped-wedge hybrid type 2 effectiveness-implementation study aims to evaluate BreeZe's effectiveness, and to evaluate the effects of our implementation approach. The study includes a pre-implementation phase (usual care), implementation phase, and a post-implementation phase (with BreeZe), and involves the three designated burn centers in the Netherlands. The phases will be rolled out sequentially from April 2024 to November 2024, and enrollment of participants concludes in July 2025.

For evaluation, this study uses the RE-AIM evaluation framework, focusing on Reach, Effectiveness, Adoption, Implementation, and Maintenance. Our co-primary outcomes are 1) BreeZe's effectiveness in improving self-management skills in burn survivors, and 2) the effects of our implementation approach on the implementation outcomes Reach, Adoption, Implementation and Maintenance. Secondary effectiveness outcomes are self-regulation, participation, dependency, and patient-centeredness for burn survivors, and self-management support skills for healthcare professionals. Data collection for burn survivors occurs at 2 weeks, 6 months, and 12 months post-discharge, using questionnaires. Data collection for healthcare professionals occurs pre-implementation, and 3, 6 and 12 months after implementation, using questionnaires, interviews, and video observations.

Conditions: Burns
Being tested: BreeZe (Brandwonden en Zelfmanagement)
Keywords: Burns, self-management, self-care, implementation, complex intervention
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BreeZe (Brandwonden en Zelfmanagement)Behavioural
BreeZe is a self-management support program designed to enhance burn survivors' intrinsic motivation and self-efficacy for self-management after discharge. The intervention is based on the Self-Regulation Theory framework. Key strategies include evidence-based techniques such as goal setting and pursuit, Solution-Focused Brief Therapy, and Motivational Interviewing. The program takes a positive approach to boost motivation and self-efficacy, promoting sustainable behavior change in burn aftercare. BreeZe will be implemented through various strategies, including educating healthcare professionals on self-management, training them in communication skills (e.g., motivational interviewing), and providing materials such as a decision aid tool (self-management web) and a workbook tailored to burn survivors. Burn survivors will use the web to identify and prioritize problems, set personalized goals with their healthcare professional, and create an action plan for goal attainment.

Study groups in NCT06782126
Study group	Role	What they receive
Pre-implementation group		Burn survivors who did not receive aftercare according to the BreeZe program
Post-implementation group		Burn survivors who received aftercare according to the BreeZe program Receives: Behavioral: BreeZe (Brandwonden en Zelfmanagement)

What is being measured

The primary outcome is the main question the study is designed to answer.

Self-management skills
The primary outcome measure is self-management skills, assessed using the revised Partners in Health (PIH) scale. This 12-item questionnaire measures self-management behavior and knowledge, with scores on a 9-point Likert scale (higher scores indicate better self-management). Two subscales are identified in the Dutch PIH: 1) knowledge and coping, and 2) recognition and management of symptoms, adherence to treatment. Higher scores reflect better self-management skills. The PIH scale has good construct validity and reliability, with Cronbach's alpha ranging from 0.82 to 0.86. Test-retest reliability, as measured by the intraclass correlation coefficient, ranges from 0.77 to 0.818 across different language versions. While no data on responsiveness is available, the PIH consistently provides valid evidence of self-management skills in patients with chronic conditions.
Measured: 2 weeks, 6 months, and 12 months after discharge from burn center
Reach
To determine reach, participant demographics will be compared to non-participants using the Dutch Burn Repository R3. We will compare the following characteristics: sex (m/f), age (years), total body surface area burned (%), operation (yes/no), and length of stay (days).
Measured: 12 months post-implementation
Adoption
Adoption at staff level will be assessed by comparing the total percentage of participating healthcare professionals to the total percentage of healthcare professionals who were invited to participate, which will be quantified in percentages. Participation is defined as the completion of the three training components (i.e., e-learning, face-to-face training, follow-up training).
Measured: 12 months post-implementation
Implementation - Intervention fidelity
To gain insight into the intervention fidelity to the core components, healthcare professionals will be asked to document in patient records when they have used certain components. A convenience sample will be taken by assessing patient records to investigate how often the core components were used, which will be described using descriptive statistics.
Measured: 12 months post-implementation
Implementation - implementation fidelity
To gain insight in the implementation fidelity to the implementation strategies, each burn center will be asked to keep track of the completion of the implementation plan, including the staff attendance to training plan and their e-learning completion rate. Implementation fidelity will be quantified using descriptive statistics.
Measured: 12 months post-implementation
Maintenance (individual level)
Maintenance will be assessed by the healthcare professionals' self-report of continued use using the Provider REport of Sustainment Scale (PRESS). The PRESS measure is a brief, reliable, and valid three-item measure of sustainment that is both pragmatic and useable across different evidence based practices (EBPs), provider types, and settings. The PRESS captures frontline staffs' report of their clinic, team, or agency's continued use of an EBP. It is measured on a 5-point Likert scale, with higher scores indicating better maintenance.
Measured: 6 and 12 months post-implementation
Maintenance (setting level)
Setting-level maintenance will be assessed via the Clinical Sustainability Assessment Tool (CSAT). The CSAT is a brief and reliable instrument consisting of 35 items within seven domains to assess an institution's capacity for sustaining a clinical practice. These domains include Engaged Staff \& Leadership, Engaged Stakeholders, Organizational Readiness, Workflow Integration, Implementation \& Training, Monitoring \& Evaluation and Outcomes \& Effectiveness. Each domain includes five items that are scored on a 7-point Likert scale, where 7 indicates an individual believes their institution has that domain to a great extent. Each domain has a min-max value of 5-35, with higher scores indicating better maintenance.
Measured: 3 and 12 months post-implementation

Secondary outcomes (12)

Self-regulation skills
Self-regulation skills will be measured with the Self-Regulation Assessment (SeRA). The SeRA consists of 22 items that assess four domains of self-regulation: 1) Insight in own health condition, 2) Insight in own capabilities, 3) Trust on self and apply self-regulation, 4) Organisation of help. Answers are given on a 5-point Likert scale. Mean scores are calculated per domain, with a min-max score of 0-40. A higher score on the scale indicates a better level of self-regulation skills.
Measured: 2 weeks, 6 months, and 12 months after discharge from burn center
Participation
Participation will be measured with the Measure of Experiential Aspects of Participation (MeEAP). Participants will be asked if they participate on four different life domains: 1) employment, 2) mobility, 3) sport, and 4) exercise. The response options will be used to assess both participation in the activity (yes vs. no) and the individual's satisfaction with the level of participation
Measured: 6 and 12 months after discharge from burn center
Daily activities
Participants will be asked if they are capable of performing their daily activities. Daily activities will be measured with one question from the 5-level EuroQoL-5D (EQ-5D-5L). Answer options are presented on a 5-point Likert scale, with a higher score indicating better capability of performing daily activities.
Measured: 2 weeks, 6 months, and 12 months after discharge from burn center
Self-care
Participants will be asked if they are capable of performing self-care. Self-care will be measured with one question from the 5-level EuroQoL-5D (EQ-5D-5L). Answer options are presented on a 5-point Likert scale, with a higher score indicating better capability of performing self-care.
Measured: 2 weeks, 6 months, and 12 months after discharge from burn center
Dependency
Participants will be asked if they are dependent on other people. Dependency will be assessed with a newly formulated question. Answer options are presented on a 5-point Likert scale with a min-max value of 1-5, with a higher score indicating less dependency on other people.
Measured: 2 weeks, 6 months, and 12 months after discharge from burn center
Return to work or school
Return to work or school will be measured with the Adjusted International Consortium for Health Outcomes Measurement. Participants will be asked about their daily occupation, with the following response options: 'I work 36 hours or more per week' (1), 'I work 35 hours or less per week' (2), 'I am job searching' (3), I do not have a paid job (I go to school or am studying)' (4), I do not have a paid job (retired, volunteer, stay-at-home occupation' (5), 'I cannot work because of my burn injury' (6), 'I cannot work due to other health issues' (7). Furthermore, they will be asked if their job has been adjusted since their burn injury (e.g. physical adjustments or reduced working hours), with 'yes' or 'no' as response options. Lastly, they will be asked, if suitable, how long after their burn injury they have started working or studying again.
Measured: 6 and 12 months after discharge from burn center
Patient centeredness
Overall experience of the received care will be assessed using the Dutch translation of the subscale 'patient-centeredness' of the American Consumer Assessment of Health Plan Survey (CAHPS). Participants will be asked if they feel listened to by their healthcare professional, if sufficient time is dedicated to their concerns, if they feel healthcare professionals take them seriously, if the healthcare professionals are able to appropriately explain things, and their level of trust in the healthcare professional's competence. Answers are measured on a 4-point Likert scale resulting in min-max values between 0-20, with higher scores indicating higher satisfaction.
Measured: 6 months after discharge from burn center
Cost-effectiveness
To evaluate the cost-effectiveness of the intervention, the complete 5-level EuroQol-5D questionnaire will be used to measure the effectiveness for patients compared to the control and intervention group. The EQ-5D questionnaire consists of five dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression. The EQ-5D L also consists the EQ visual analogue scale (VAS). Answer options are given on a 5-point Likert scale.
Measured: 2 weeks, 6 months, and 12 months after discharge from burn center
Self-management support skills
Self-management support skills of participating healthcare professionals will be measured with the Self-efficacy and Performance in Self-management Support (SEPSS-36). The SEPSS is a 36-item questionnaire divided over 6 subscales, using a 5-point Likert-scale. Higher mean scores (overall and for subscales) indicate a higher level of self-efficacy or performance in self-management support. Min-max values for the subscales range from 0-24, and the overall min-max value range from 0-144.
Measured: Before implementation, 3, 6, and 12 months post-implementation
Need-supportive counselling
Need-supportive counselling will be measured using two separate taxonomies. The first taxonomy is the Coding and Observing Need-Supportive Counselling in Chronic Care Encounters (COUNSEL-CCE). The COUNSEL-CCE consists of 44 items divided into nine scales of behavioral approaches. Response options are based on a 5-point Likert scale range from 'never observed' (0) to 'all the time observed' (4). Min-max values range from 0-24, with higher scores indicating better need-supportive counselling.
Measured: Before implementation, 3 and 12 months post-implementation
Perspectives on Adoption, Implementation, and Maintenance
To explore healthcare professionals' perspectives on adoption, implementation, and maintenance, we will conduct Consolidated Framework for Implementation Research (CFIR)-informed interviews with all participating healthcare professionals. These interviews will be used to provide working hypotheses to explain the degree of adoption, to explain implementation success or failure, and to explain the degree of maintenance.
Measured: 6 months post-implementation
Need-supportive counselling
The second taxonomy to assess need-supportive counselling is the Nurse-Child Interaction Taxonomy (NCIT). The NCIT consists of 16 items divided over 3 subdomains, scored on a 7-point scale, with higher scores indicating better need-supportive counselling.
Measured: Before implementation, 3 and 12 months post-implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202414 Jul 2026

First posted17 Jan 2025
Study start15 Apr 2024
Primary completion14 Jul 2026 (estimated)
Study completion14 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 146 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06782126
Sponsor's protocol ID: nr. 2024-033, nr 2024-048
Other IDs: 10070022010003
Acronym: BET
Status last verified: Feb 2026
First submitted: 6 Jan 2025
Last updated: 25 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Spronk I, van Uden D, van Dammen L, van Baar ME, Nieuwenhuis M, Pijpe A, Visser I, van Schie C, van Zuijlen P, Haanstra T, Lansdorp CA; Dutch Burn Care, Education & Research group. Outcomes that matter most to burn patients: A national multicentre survey study in the Netherlands. Burns. 2024 Feb;50(1):31-40. doi: 10.1016/j.burns.2023.10.018. Epub 2023 Nov 10.
PubMed 37985268
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801
Caron JG, Martin Ginis KA, Rocchi M, Sweet SN. Development of the Measure of Experiential Aspects of Participation for People With Physical Disabilities. Arch Phys Med Rehabil. 2019 Jan;100(1):67-77.e2. doi: 10.1016/j.apmr.2018.08.183. Epub 2018 Sep 27.
PubMed 30268805
Petkov J, Harvey P, Battersby M. The internal consistency and construct validity of the partners in health scale: validation of a patient rated chronic condition self-management measure. Qual Life Res. 2010 Sep;19(7):1079-85. doi: 10.1007/s11136-010-9661-1. Epub 2010 May 1.
PubMed 20437206
Maes S, Karoly P. Self-regulation assessment and intervention in physical health and illness: A review. Appl Psychol. 2005;54:267-299. doi:10.1111/j.1464-0597.2005.00210.x.
Dokter J, Vloemans AF, Beerthuizen GI, van der Vlies CH, Boxma H, Breederveld R, Tuinebreijer WE, Middelkoop E, van Baar ME; Dutch Burn Repository Group. Epidemiology and trends in severe burns in the Netherlands. Burns. 2014 Nov;40(7):1406-14. doi: 10.1016/j.burns.2014.03.003. Epub 2014 Apr 2.
PubMed 24703338
Arah OA, ten Asbroek AH, Delnoij DM, de Koning JS, Stam PJ, Poll AH, Vriens B, Schmidt PF, Klazinga NS. Psychometric properties of the Dutch version of the Hospital-level Consumer Assessment of Health Plans Survey instrument. Health Serv Res. 2006 Feb;41(1):284-301. doi: 10.1111/j.1475-6773.2005.00462.x.
PubMed 16430612
Delnoij DM, ten Asbroek G, Arah OA, de Koning JS, Stam P, Poll A, Vriens B, Schmidt P, Klazinga NS. Made in the USA: the import of American Consumer Assessment of Health Plan Surveys (CAHPS) into the Dutch social insurance system. Eur J Public Health. 2006 Dec;16(6):652-9. doi: 10.1093/eurpub/ckl023. Epub 2006 Mar 8.
PubMed 16524940
Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.
PubMed 33284428
Mol TI, van Bennekom CAM, Scholten EWM, Visser-Meily JMA, Beckerman H, Passier PECA, Smeets RJEM, Schiphorst Preuper HR, Post MWM. The Self-Regulation Assessment (SeRA) questionnaire: development and exploratory analyses of a new patient-reported outcome measure for rehabilitation. Disabil Rehabil. 2023 Jun;45(12):2038-2045. doi: 10.1080/09638288.2022.2080289. Epub 2022 Jun 7.
PubMed 35672153
Chiu TM, Tam KT, Siu CF, Chau PW, Battersby M. Validation study of a Chinese version of Partners in Health in Hong Kong (C-PIH HK). Qual Life Res. 2017 Jan;26(1):199-203. doi: 10.1007/s11136-016-1315-5. Epub 2016 May 23.
PubMed 27216940
Hudon E, Chouinard MC, Krieg C, Lambert M, Joober H, Lawn S, Smith D, Lambert S, Hudon C. The French adaptation and validation of the Partners in Health (PIH) scale among patients with chronic conditions seen in primary care. PLoS One. 2019 Oct 23;14(10):e0224191. doi: 10.1371/journal.pone.0224191. eCollection 2019.
PubMed 31644561
Lenferink A, Effing T, Harvey P, Battersby M, Frith P, van Beurden W, van der Palen J, Paap MC. Construct Validity of the Dutch Version of the 12-Item Partners in Health Scale: Measuring Patient Self-Management Behaviour and Knowledge in Patients with Chronic Obstructive Pulmonary Disease. PLoS One. 2016 Aug 26;11(8):e0161595. doi: 10.1371/journal.pone.0161595. eCollection 2016.
PubMed 27564410
Blok SL, Nieuwenhuis MK, Scholten-Jaegers SMHJ, Visser I, Thambithurai RSM, de Craen-de Moor MACM, Baran KC, Niemeijer AS, Bosma E, van der Sluis CK, Geelen SJG; National Burn Care, Education & Research Group, The Netherlands. Self-Management Support After Burns: Protocol for a Multicenter, Stepped-Wedge Hybrid Type II Effectiveness-Implementation Study. JMIR Res Protoc. 2026 Mar 16;15:e86671. doi: 10.2196/86671.
PubMed 41838889

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-management Support After Burns: Study Protocol for a Multicenter Stepped-wedge Hybrid Type 2 Effectiveness-implementation Study
ClinicalTrials.gov ID: NCT06782126
Acronym / sponsor ID: BET / nr. 2024-033, nr 2024-048
Conditions: Burns
Keywords: Burns, self-management, self-care, implementation, complex intervention
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 146 participants (estimated)
Lead sponsor: Martini Hospital GroningenUniversity, hospital or other
Collaborators: Maasstad Hospital, Rotterdam, Rode Kruis Ziekenhuis Beverwijk
Study start: 15 Apr 2024 (actual)
Primary completion: 14 Jul 2026 (estimated)
Study completion: 14 Jul 2026 (estimated)
First posted: 17 Jan 2025 (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.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pre-implementation group	–	–Burn survivors who did not receive aftercare according to the BreeZe program
Post-implementation group	–	Behavioral: BreeZe (Brandwonden en Zelfmanagement)Burn survivors who received aftercare according to the BreeZe program

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The Emergency Management of Severe Burns (EMSB) referral criteria guide the decision to refer burn patients to a specialized burn center. Criteria for referral include: 1) total burned body surface area (TBSA) >10%, 2) >5% full-thickness burns, 3) circular burns around the neck, thorax, or extremities, 4) burns around functional areas, 5) burns with other trauma, 6) chemical burns, 7) pre-existing diseases, or 8) electrical burns. Minor burns may be managed in tertiary trauma centers or non-burn facilities, but most burn survivors are either directly admitted or transferred to a burn center. In the Netherlands, approximately 800 burn survivors are admitted to one of the three designated burn centers annually. These centers meet specific criteria for expertise, facilities, and quality of care to provide optimal treatment for burn patients.

Key inclusion criteria (3 listed)

18 years or older
Admission in one of the burn centers > 24 hours and/or debridement or skin graft operation
Proficiency of the Dutch language

Key exclusion criteria (3 listed)

Acute psychiatric illness
Cognitive limitations
Discharge to a different healthcare institution

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
BreeZe (Brandwonden en Zelfmanagement)BreeZe is a self-management support program designed to enhance burn survivors' intrinsic motivation and self-efficacy for self-management after discharge. The intervention is based on the Self-Regulation Theory framework. Key strategies include evidence-based techniques such as goal setting and pursuit, Solution-Focused Brief Therapy, and Motivational Interviewing. The program takes a positive approach to boost motivation and self-efficacy, promoting sustainable behavior change in burn aftercare. BreeZe will be implemented through various strategies, including educating healthcare professionals on self-management, training them in communication skills (e.g., motivational interviewing), and providing materials such as a decision aid tool (self-management web) and a workbook tailored to burn survivors. Burn survivors will use the web to identify and prioritize problems, set personalized goals with their healthcare professional, and create an action plan for goal attainment.	Behavioural	Post-implementation group

Primary outcome

Self-management skills
Time frame: 2 weeks, 6 months, and 12 months after discharge from burn center
The primary outcome measure is self-management skills, assessed using the revised Partners in Health (PIH) scale. This 12-item questionnaire measures self-management behavior and knowledge, with scores on a 9-point Likert scale (higher scores indicate better self-management). Two subscales are identified in the Dutch PIH: 1) knowledge and coping, and 2) recognition and management of symptoms, adherence to treatment. Higher scores reflect better self-management skills. The PIH scale has good construct validity and reliability, with Cronbach's alpha ranging from 0.82 to 0.86. Test-retest reliability, as measured by the intraclass correlation coefficient, ranges from 0.77 to 0.818 across different language versions. While no data on responsiveness is available, the PIH consistently provides valid evidence of self-management skills in patients with chronic conditions.
Reach
Time frame: 12 months post-implementation
To determine reach, participant demographics will be compared to non-participants using the Dutch Burn Repository R3. We will compare the following characteristics: sex (m/f), age (years), total body surface area burned (%), operation (yes/no), and length of stay (days).
Adoption
Time frame: 12 months post-implementation
Adoption at staff level will be assessed by comparing the total percentage of participating healthcare professionals to the total percentage of healthcare professionals who were invited to participate, which will be quantified in percentages. Participation is defined as the completion of the three training components (i.e., e-learning, face-to-face training, follow-up training).
Implementation - Intervention fidelity
Time frame: 12 months post-implementation
To gain insight into the intervention fidelity to the core components, healthcare professionals will be asked to document in patient records when they have used certain components. A convenience sample will be taken by assessing patient records to investigate how often the core components were used, which will be described using descriptive statistics.
Implementation - implementation fidelity
Time frame: 12 months post-implementation
To gain insight in the implementation fidelity to the implementation strategies, each burn center will be asked to keep track of the completion of the implementation plan, including the staff attendance to training plan and their e-learning completion rate. Implementation fidelity will be quantified using descriptive statistics.
Maintenance (individual level)
Time frame: 6 and 12 months post-implementation
Maintenance will be assessed by the healthcare professionals' self-report of continued use using the Provider REport of Sustainment Scale (PRESS). The PRESS measure is a brief, reliable, and valid three-item measure of sustainment that is both pragmatic and useable across different evidence based practices (EBPs), provider types, and settings. The PRESS captures frontline staffs' report of their clinic, team, or agency's continued use of an EBP. It is measured on a 5-point Likert scale, with higher scores indicating better maintenance.
Maintenance (setting level)
Time frame: 3 and 12 months post-implementation
Setting-level maintenance will be assessed via the Clinical Sustainability Assessment Tool (CSAT). The CSAT is a brief and reliable instrument consisting of 35 items within seven domains to assess an institution's capacity for sustaining a clinical practice. These domains include Engaged Staff \& Leadership, Engaged Stakeholders, Organizational Readiness, Workflow Integration, Implementation \& Training, Monitoring \& Evaluation and Outcomes \& Effectiveness. Each domain includes five items that are scored on a 7-point Likert scale, where 7 indicates an individual believes their institution has that domain to a great extent. Each domain has a min-max value of 5-35, with higher scores indicating better maintenance.

12 secondary outcomes

Self-regulation skills
Time frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Participation
Time frame: 6 and 12 months after discharge from burn center
Daily activities
Time frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Self-care
Time frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Dependency
Time frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Return to work or school
Time frame: 6 and 12 months after discharge from burn center
Patient centeredness
Time frame: 6 months after discharge from burn center
Cost-effectiveness
Time frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Self-management support skills
Time frame: Before implementation, 3, 6, and 12 months post-implementation
Need-supportive counselling
Time frame: Before implementation, 3 and 12 months post-implementation
Perspectives on Adoption, Implementation, and Maintenance
Time frame: 6 months post-implementation
Need-supportive counselling
Time frame: Before implementation, 3 and 12 months post-implementation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
Background: PubMed 37985268Spronk I, van Uden D, van Dammen L, van Baar ME, Nieuwenhuis M, Pijpe A, Visser I, van Schie C, van Zuijlen P, Haanstra T, Lansdorp CA; Dutch Burn Care, Education & Research group. Outcomes that matter most to burn patients: A national multicentre survey study in the Netherlands. Burns. 2024 Feb;50(1):31-40. doi: 10.1016/j.burns.2023.10.018. Epub 2023 Nov 10.
Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Background: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Background: PubMed 30268805Caron JG, Martin Ginis KA, Rocchi M, Sweet SN. Development of the Measure of Experiential Aspects of Participation for People With Physical Disabilities. Arch Phys Med Rehabil. 2019 Jan;100(1):67-77.e2. doi: 10.1016/j.apmr.2018.08.183. Epub 2018 Sep 27.
Background: PubMed 20437206Petkov J, Harvey P, Battersby M. The internal consistency and construct validity of the partners in health scale: validation of a patient rated chronic condition self-management measure. Qual Life Res. 2010 Sep;19(7):1079-85. doi: 10.1007/s11136-010-9661-1. Epub 2010 May 1.
BackgroundMaes S, Karoly P. Self-regulation assessment and intervention in physical health and illness: A review. Appl Psychol. 2005;54:267-299. doi:10.1111/j.1464-0597.2005.00210.x.
Background: PubMed 24703338Dokter J, Vloemans AF, Beerthuizen GI, van der Vlies CH, Boxma H, Breederveld R, Tuinebreijer WE, Middelkoop E, van Baar ME; Dutch Burn Repository Group. Epidemiology and trends in severe burns in the Netherlands. Burns. 2014 Nov;40(7):1406-14. doi: 10.1016/j.burns.2014.03.003. Epub 2014 Apr 2.
Background: PubMed 16430612Arah OA, ten Asbroek AH, Delnoij DM, de Koning JS, Stam PJ, Poll AH, Vriens B, Schmidt PF, Klazinga NS. Psychometric properties of the Dutch version of the Hospital-level Consumer Assessment of Health Plans Survey instrument. Health Serv Res. 2006 Feb;41(1):284-301. doi: 10.1111/j.1475-6773.2005.00462.x.
Background: PubMed 16524940Delnoij DM, ten Asbroek G, Arah OA, de Koning JS, Stam P, Poll A, Vriens B, Schmidt P, Klazinga NS. Made in the USA: the import of American Consumer Assessment of Health Plan Surveys (CAHPS) into the Dutch social insurance system. Eur J Public Health. 2006 Dec;16(6):652-9. doi: 10.1093/eurpub/ckl023. Epub 2006 Mar 8.
Background: PubMed 33284428Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.
Background: PubMed 35672153Mol TI, van Bennekom CAM, Scholten EWM, Visser-Meily JMA, Beckerman H, Passier PECA, Smeets RJEM, Schiphorst Preuper HR, Post MWM. The Self-Regulation Assessment (SeRA) questionnaire: development and exploratory analyses of a new patient-reported outcome measure for rehabilitation. Disabil Rehabil. 2023 Jun;45(12):2038-2045. doi: 10.1080/09638288.2022.2080289. Epub 2022 Jun 7.
Background: PubMed 27216940Chiu TM, Tam KT, Siu CF, Chau PW, Battersby M. Validation study of a Chinese version of Partners in Health in Hong Kong (C-PIH HK). Qual Life Res. 2017 Jan;26(1):199-203. doi: 10.1007/s11136-016-1315-5. Epub 2016 May 23.
Individual participant dataSharing planned: Yes

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Burns, run by Martini Hospital Groningen at 3 sites in Netherlands.

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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

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?

Self-management skills (time frame: 2 weeks, 6 months, and 12 months after discharge from burn center). The study lists 7 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 NCT06782126, which also lists 15 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 25 Feb 2026.