The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUlla Riis Madsen
About this trial
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).
The 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.
The 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.
The feasibility study is conducted at two DFU clinics in Denmark and consists of four complementary sub-studies using qualitative and quantitative methods.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years.
Have a diabetic foot ulcer (DFU).
Receive care at one of the two participating outpatient wound clinics.
Are offered and participate in a Status Conversation as part of the ProActive model in routine clinical practice.
Disqualifiers
Unable to provide informed consent.
Do not otherwise meet the relevant inclusion criteria.
Aged ≥18 years.
Have a diabetic foot ulcer (DFU).
Trial population
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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
484 Participants
are grouped into 4 trial groupsGroup A: Health care professionals
Group B: Patients and relatives- interview
Group C: Patients and relatives- questionaires
Group D: Patients - retrospective clinical data
Trial outcomes
Primary outcomes
1
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.
Time frame
After the 3-month test phase2
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.
Time frame
After the 3-month test phase3
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.
Time frame
After the 3-month test phase4
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.
Time frame
After the 3-month test phaseLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ulla Riis Madsen
Lead sponsor
Zealand University Hospital
Sponsor institution
Kolding Sygehus
Collaborator
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Collaborator
Steno Diabetes Center Copenhagen
Collaborator
Steno Diabetes Center Sjaelland
Collaborator
Independent Research Fund Denmark
Collaborator
OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: