[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653152":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":34,"overallOfficials":34,"centralContacts":51,"locations":34,"responsibleParty":61,"collaborators":65,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":34,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":34,"enrollmentInfo":90,"targetDuration":34,"studyType":93,"phases":34,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":104,"whyStopped":34,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":34},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":34},[9,13,16,19,22,26,30],{"measure":10,"description":11,"timeFrame":12},"Acceptability of the ProActive model assessed by AIM","Acceptability of the ProActive model will be assessed among clinicians using the Acceptability of Intervention Measure (AIM). AIM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived acceptability.","After the 3-month test phase",{"measure":14,"description":15,"timeFrame":12},"Feasibility of the ProActive model assessed by FIM","Feasibility of the ProActive model will be assessed among clinicians using the Feasibility of Intervention Measure (FIM). FIM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived feasibility.",{"measure":17,"description":18,"timeFrame":12},"Appropriateness of the ProActive model assessed by IAM","Appropriateness of the ProActive model will be assessed among clinicians using the Intervention Appropriateness Measure (IAM). IAM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived appropriateness.",{"measure":20,"description":21,"timeFrame":12},"Clinician experiences of ProActive implementation assessed by focus group interviews","Clinicians' experiences of implementing ProActive in routine diabetic foot ulcer care will be explored through post-intervention focus group interviews. Interviews will address implementation, local adaptation, interdisciplinary collaboration, barriers and facilitators, and integration into routine clinical practice.",{"measure":23,"description":24,"timeFrame":25},"Patient and relative experiences of Status Conversations assessed by interviews","Patient and relative experiences of ProActive will be explored through semi-structured interviews after participation in a Status Conversation. Interviews will address experiences of being met with a proactive palliative care approach, perceived relevance and timing of the Status Conversation, preparation, emotional impact, involvement of relatives, and perceived benefits and challenges.","Approximately 3 weeks after the Status Conversation",{"measure":27,"description":28,"timeFrame":29},"Feasibility of patient-reported questionnaire completion","Feasibility of patient-reported questionnaire completion will be assessed descriptively using response rates, completeness of questionnaire data, missing data, and timing of completion for patient-reported questionnaires.","Baseline, 1 month, and 3 months after the Status Conversation",{"measure":31,"description":32,"timeFrame":33},"Feasibility of identification procedures for Status Conversations","Feasibility of identification procedures will be assessed descriptively using the proportion of eligible patients assessed for potential relevance for a Status Conversation, identified as potentially relevant, offered a Status Conversation, and accepting or declining the conversation.","During the 12-month test phase, with retrospective assessment after 1-year follow-up",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":6,"timePerspective":6,"maskingInfo":34},"People with diabetic foot ulcers (DFU) may live with substantial symptom burden, impaired quality of life, uncertainty, and complex care needs. Despite the serious health consequences associated with DFU, a palliative approach is not routinely integrated into DFU care. The ProActive study therefore investigates the feasibility of integrating a proactive palliative care approach into routine DFU care.\n\nThe ProActive model includes systematic procedures for identifying patients who may benefit from a palliative approach and structured serious illness conversations (SIC). The conversations provide an opportunity to discuss the patient's understanding of their health situation, concerns, priorities, and preferences for future care. Relatives may participate when appropriate.\n\nHealthcare professionals at the participating DFU clinics receive training and support to deliver the intervention and integrate it into existing clinical practice. The implementation process is informed by the Medical Research Council framework for developing and evaluating complex interventions, with particular attention to context, stakeholder involvement, and uncertainties related to feasibility.\n\nStudy 1 investigates the feasibility of the ProActive model and its implementation from the perspective of healthcare professionals. Data are collected through observations during implementation activities and focus group interviews with healthcare professionals (N=14). Particular attention is given to the acceptability, appropriateness, and feasibility of the intervention and its implementation in routine DFU care.\n\nStudy 2 explores patients' and relatives' experiences of the ProActive model and SIC. Patients participating in the intervention, and relatives when applicable, are invited to qualitative interviews exploring their experiences of the conversation and the relevance and acceptability of introducing a proactive palliative approach in DFU care. The study includes up to 20 patients and their relatives.\n\nStudy 3 evaluates the feasibility of outcome measures and data collection procedures intended for use in a future effectiveness evaluation. Patient-, relative-, and healthcare professional-reported measures are collected to assess completion, timing, participant burden, and the suitability of the selected measures and procedures. The study includes up to 50 patients and their relatives where applicable, and 14 healthcare professionals.\n\nStudy 4 evaluates the procedures used to identify and recruit patients who may benefit from the ProActive model. All patients with DFU referred to the participating clinics during the 12-month test phase (N=400) are included in a retrospective assessment of identification and recruitment procedures and selected clinical outcomes.\n\nFindings from the four sub-studies will be integrated to assess the overall feasibility of the ProActive model and its implementation and to identify refinements needed before a future evaluation of effectiveness.","The study population comprises adult patients with diabetic foot ulcers (DFU) receiving care at two participating outpatient wound clinics, their relatives or close persons where applicable, and healthcare professionals involved in DFU care and in the implementation and delivery of the ProActive model. For Studies 1-3, patient participants are those who are offered and participate in a Status Conversation as part of the ProActive model. Study 4 includes the broader population of all adult patients with DFU who are newly referred to the participating clinics during the 12-month test phase or who develop a new or recurrent DFU during ongoing follow-up, regardless of whether they are offered or participate in a Status Conversation.",[39,42,45,48],{"label":40,"type":34,"description":41,"interventionNames":34},"Health care professionals","Healthcare professionals involved in the care of patients with diabetic foot ulcers (DFU) at the participating clinics. Healthcare professionals will take part in the structured implementation activities, including workshops and communication training, and will subsequently deliver the ProActive intervention, including adapted serious illness conversations (SIC), as part of routine DFU care.",{"label":43,"type":34,"description":44,"interventionNames":34},"Patients and relatives- interview","Patients with diabetic foot ulcers (DFU) receiving care at the participating clinics and, where applicable, their relatives. Patients will receive the ProActive intervention, including an adapted serious illness conversation (SIC) as part of routine DFU care. Patients and relatives will subsequently be invited to participate in interviews exploring their experiences of the ProActive intervention, including the SIC and the proactive palliative care approach.",{"label":46,"type":34,"description":47,"interventionNames":34},"Patients and relatives- questionaires","Patients with diabetic foot ulcers (DFU) receiving care at the participating clinics and, where applicable, their relatives. Participants will complete questionnaires to assess the feasibility of selected outcome measures and data collection procedures for a future effectiveness evaluation of the ProActive intervention. Patients will complete questionnaires before the intervention and at 1 and 3 months after the intervention, while relatives will complete a questionnaire according to the study procedures.",{"label":49,"type":34,"description":50,"interventionNames":34},"Patients - retrospective clinical data","All patients with diabetic foot ulcers (DFU) referred to the participating clinics during the 12-month test phase. Routinely collected clinical data will be used retrospectively to assess the feasibility of the patient identification and recruitment procedures and to describe relevant clinical outcomes during the study period.",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":34,"email":56},"Ulla Riis Madsen, PhD","CONTACT","+4593576367","urm@regionsjaelland.dk",{"name":58,"role":54,"phone":59,"phoneExt":34,"email":60},"Trine Herskind Hasløv, MSc","+4522475483","trhh@regionsjaelland.dk",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Ulla Riis Madsen","Associate Professor",[66,68,70,72,75,78],{"name":67,"class":6},"Kolding Sygehus",{"name":69,"class":6},"REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care",{"name":71,"class":6},"Steno Diabetes Center Copenhagen",{"name":73,"class":74},"Steno Diabetes Center Sjaelland","OTHER_GOV",{"name":76,"class":77},"Independent Research Fund Denmark","INDUSTRY",{"name":79,"class":80},"OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark","UNKNOWN","100653152","the-proactive-study--integrating-a-proactive-and-palliative-care-approach-to-diabetic-ulcer-care-100653152",false,"NCT07781111","The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care","The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care. A Feasibility Study.","Study 1-3:\n\nInclusion Criteria:\n\nHealth professionals:\n\n\\- Healthcare professionals involved in DFU care and in the implementation and delivery of the ProActive model at one of the participating sites, including specialized wound care nurses and vascular or orthopaedic surgeons.\n\nPatient and relatives\n\n* Aged ≥18 years.\n* Have a diabetic foot ulcer (DFU).\n* Receive care at one of the two participating outpatient wound clinics.\n* Are offered and participate in a Status Conversation as part of the ProActive model in routine clinical practice.\n* Are able to provide informed consent.\n\nExclusion Criteria:\n\nHealthcare professionals:\n\n-Not involved in DFU care or in the implementation or delivery of the ProActive model at the participating sites.\n\nPatients and relatives:\n\n* Unable to provide informed consent.\n* Do not otherwise meet the relevant inclusion criteria.\n\nStudy 4:\n\nInclusion Criteria:\n\n* Aged ≥18 years.\n* Have a diabetic foot ulcer (DFU).\n* Are newly referred to one of the participating outpatient wound clinics during the 12-month test phase, or develop a new or recurrent DFU during ongoing follow-up at one of the participating clinics.\n* Included regardless of whether they are identified as potentially relevant for, offered, or participate in a Status Conversation.\n\nExclusion Criteria:\n\n* Patients who are not newly referred during the test phase and who do not develop a new or recurrent DFU during ongoing follow-up at one of the participating clinics.\n* Patients with insufficient Danish language skills to understand questionnaires or study instructions, or with cognitive impairment that prevents understanding of instructions or participation in a Status Conversation.","ALL","18 Years",{"count":91,"type":92},484,"ESTIMATED","OBSERVATIONAL","The ProActive study aims to investigate the feasibility of integrating a proactive palliative care approach into routine care for people with diabetic foot ulcers (DFU).\n\nThe ProActive model includes procedures to identify patients who may benefit from a palliative approach and structured serious illness conversations (SIC) addressing patients' health situation, concerns, priorities, and preferences for care. Relatives may be involved when appropriate.\n\nThe study examines the feasibility, acceptability, and appropriateness of the ProActive model and its implementation from the perspectives of patients, relatives, and healthcare professionals. It also evaluates the feasibility of outcome measures and data collection procedures for a future effectiveness study and examines the procedures used to identify patients who may benefit from the intervention.\n\nThe feasibility study is conducted at two DFU clinics in Denmark and consists of four complementary sub-studies using qualitative and quantitative methods.",[96,97,98],"Diabetic Foot Ulcer (DFU)","Palliative Care","Advance Care Planning",[100,101,102,103],"ProActive","serious illness conversations","palliative care","diabetic foot ulcer","NOT_YET_RECRUITING","2026-08-21",{"date":107,"type":108},"2026-08-24","ACTUAL",{"date":110,"type":92},"2026-09-01",{"date":112,"type":92},"2029-02-28",{"name":63,"class":6}]