StrokeNCT06065397
Goal-setting in Stroke: From Guideline Towards Implementation: a Realist Evaluation
A study testing Goal setting improvement program in people with Stroke, run by Hasselt University at 1 site in Belgium.
Trial summary
Overall objective: The aim of the project is to integrate the quality improvement programme on goal setting into the current care of people with stroke and to test and refine this programme. Target group: 1. People after a stroke (treatment in the participating centres); total number 155 people 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Goal setting improvement program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jan 2023to 30 Mar 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are employed in hospitals, rehabilitation centres and/or private practices/primary healthcare facilities located in the provinces: Province of Flemish Brabant, Brussels, Province of Walloon Brabant, Limburg
- Participants have a social, medical profession/background, work in the management of healthcare services or quality of healthcare
- Participants involved (direct or indirect) in the goal-setting process of the patients
- Participants who master the Flemish or French language
- Adult participants (≥18 years)
- Participants after a stroke event.
Show all 10Show fewer
- Residence in one of the four participating sites, in outpatient care or receive treatment in first line zone
- Participants who master the Flemish or French language
- Adult participants (≥18 years)
- Informal caregiver of a stroke patient admitted to one of the four participating sites
Who cannot join
- Not giving informed consent
- Patients
- Not giving informed consent
- Other severe comorbidities that interfere with the rehabilitation process or goal-setting process
- Informal caregivers
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UHasselt
Hasselt, Limburg, 3500
Liselot Thijs, Phd, 003222862653, liselot.thijs@uhasselt.be
About this study
Overall objective: The aim of the project is to integrate the quality improvement programme on goal setting into the current care of people with stroke and to test and refine this programme.
Target group:
Read more
- People after a stroke (treatment in the participating centres); total number 155 people
- Informal carers (only if the person has had a stroke and has limited opportunities to participate)
- Professional carer; total number 155 people
What?
The goal-setting programme becomes standard care, it is checked whether the programme has been applied in care by health professionals (review of the patient's medical record), what the effects are on patients (questionnaires) and health professionals (questionnaires) and whether the quality improvement programme needs to be adjusted or refined (interviews with health professionals and the patient group)
When to evaluate?
- Health professionals: start of the study and end of the study via questionnaires. Interviews/focus group (every 3 months)
- Review of patient records and observations (every 3 weeks)
- Patient assessment: Admission and 1 week before discharge or end of study, Interviews/focus group (3 months)
Read the detailed description
Aim This study aims to evaluate the implementation of a quality improvement program to improve goal-setting in the rehabilitation process after a stroke event (further referred to as goal-setting programme) by means of a realist evaluation.
During this project, following questions will be answered:
What are the different elements and the final form of the initial goal-setting programme? How is goal-setting for the implementation of the goal-setting programme conducted? How is the goal-setting programme implemented? Is the goal-setting programme accepted, is it appropriate and feasible to implement? (review the implementation process).
Are adjustments needed on the goal-setting programme? How are the adjustments in the goal-setting programme being followed up? (review the implementation process) Does the implementation of the goal-setting programme in healthcare have an effect for patient or professional healthcare providers? (patient and healthcare professional outcome: Satisfaction with stroke care, participation, emotional status, empowerment and quality of life and overall feeling on goal-setting in stroke care)
- Conditions
- Stroke
- Being tested
- Goal setting improvement program
- Keywords
- Implementation, Realist evaluation, Stroke, Improvement program, Goal setting
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal setting improvement programProcedure or surgery
A improvement program how to optimalize patient-centered goal setting in rehab care is being implemented.
| Study group | Role | What they receive |
|---|---|---|
| People after a stroke event | Experimental | Implementation of improvement program Receives: Procedure: Goal setting improvement program |
| Healthcare professionals | Experimental | Implementation of improvement program Receives: Procedure: Goal setting improvement program |
| Close relatives of people after a stroke | Experimental | Implementation of improvement program Receives: Procedure: Goal setting improvement program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption and adherence of goal-setting programme- in acute care setting
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
Measured: Once up to 3 weeks during the hospitalisation period, through study completion, an average of 1 year
Adoption and adherence of goal-setting programme- in rehabilitation setting
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
Measured: Every 3 weeks during the hospitalisation period, through study completion, an average of 1 year
Secondary outcomes (10)
Evaluation of patient/ informal caregivers: Measuring patient satisfaction with stroke care
- Measuring patient satisfaction with stroke care: Satisfaction with stroke care questionnaire, In this evaluation, patients are asked to evaluate the care and treatment in the health facility using a 4-point Likert scale, ranging from strongly disagree to strongly agree. On the other hand, the preparation for discharge from hospital and the subsequent period are also surveyed. The latter is conducted only in patients transferred from a participating center or in those going home after admission to rehabilitation. The higher the outcome score the higher the stroke patients' and informal caregivers' satisfaction is with hospital stroke care.
Measured: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers: Patient Participation
- Patient Participation: Via the Patient Participation in Rehabilitation Questionnaire, patients' experiences of participation in their rehabilitation will be assessed. This evaluation will be evaluated as an optional scale. Only for participants who are able to fulfill this questionnaire based on cognition or on level of load ability. The Patient Participation in Rehabilitation Questionnaire contains 20 items, scoring is based on a five point-likert scale varying from always agree to never agree. The higher the score the higher according to the patient/informal caregiver wishes the involved in their care is.
Measured: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, Patient empowerment:
- Patient empowerment: Through the Health Care Empowerment Inventory, patients or informal caregivers are asked about their engagement with the patient about their healthcare. Using eight statements, the patient or informal caregiver must indicate the extent to which they agree or disagree with each of the following statements. The higher the score the higher the patient/informal caregiver wishes to be involved in their healthcare.
Measured: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, Level of depression:
- Level of depression: Via the Patient Health Questionnaire-9 (PHQ-9) the mental functioning is evaluated. The PHQ-9 is the depression module, which scores each of the 9 Diagnostic Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). The lower the score, the lower the change of a depression are.
Measured: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, general Self-Efficacy
- Level of helplessness/self-efficacy scale The first questionnaire evaluated the level of self-efficiency through the General Self-Efficacy Scale. This questionnaire is a mandatory questionnaire. The General Self-Efficacy Scale concerns a unidimensional questionnaire that measures how a person generally copes with stressors/difficult situations in life. It involves ten statements (optimistic 'self-beliefs') that ask about how one thinks and acts in general. The scale consists of 10 statements. For each statement, responders must answer on a 4-point likert scale, ranging from completely incorrect to completely correct. The higher the score, the more confident the patient/informal caregiver is that his or her actions are responsible for successful outcomes.
Measured: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, stroke self-efficacy:
- Level of helplessness/self-efficacy scale The second questionnaire evaluated the level of self-efficiency through the Stroke self-efficacy questionnaire. This questionnaire is an optional questionnaire. The Stroke self-efficacy questionnaire is a 13-item self-report scale measuring self-efficacy judgements in specific domains of functioning post stroke. Individuals rate their belief in their ability to achieve each of the 13 items on a 10-point scale, where 0 = not at all confident to 10 = very confident. The higher the score the higher the patient/informal caregiver's self-confidence in functional performance.
Measured: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of professional healthcare providers: Satisfaction of employees in healthcare
- Satisfaction of employees in healthcare survey Through the Satisfaction of employees in healthcare survey, 20 statements are shown to healthcare professionals. For each statement, healthcare professionals have to score the statement using a 4 point likert scale, ranging from strongly disagree to strongly agree. A higher score indicated on the statement corresponds to a higher level of satisfaction with their work setting.
Measured: Baseline and immediately after the intervention
Evaluation of professional healthcare providers; Self- efficacy
- Self- efficacy in patient centeredness questionnaire A 27-statement questionnaire asks healthcare professionals about how doctors and caregivers interact and communicate with patients. Participants can answer using a 5-point likert scale ranging from the answer option very little to very much. This questionnaire contains 3 main topics; 1) exploring the patient perspective, 2) sharing information and power and 3) Dealing with communicative challenges. A higher score corresponds to more confidence in dealing with patients.
Measured: Baseline and immediately after the intervention
Evaluation of professional healthcare providers; Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure questionnaire
Through a questionnaire (Acceptability of Intervention Measure, Intervention Appropriateness Measure, \& Feasibility of Intervention Measure questionnaire) professional healthcare professionals are asked if they can assess whether the programme is appropriate and feasible and whether they accept the programme. A total of 12 statements are presented to participants where for each statement the participant has to indicate via a 5-point likert scale (ranging from Completely disagree to Completely agree) to what extent they agree or disagree with the statement.
Measured: 1-2 months after study start, at 4 months after study start and immediately after the intervention
Feedback on the goal setting programme and implementation strategies.
Through a semi-structured interview or focus group, both professional caregivers and patients/ informal caregivers are asked for their feedback on the programme and the implementation strategies used.
Measured: 2-3, 5 and 8 months after study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start17 Jan 2023
- Primary completion23 Sep 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Public Service Health, Food Chain Safety and Environment
- Responsible party
- Principal investigator, Annemie Spooren, Hasselt University
- Investigators
- Annemie Spooren, prof dr, Principal investigator, UHasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065397
- Sponsor's protocol ID
- Goal setting in Stroke
- Status last verified
- Oct 2023
- First submitted
- 28 Feb 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-setting in Stroke: From Guideline Towards Implementation: a Realist Evaluation
- ClinicalTrials.gov ID
- NCT06065397
- Acronym / sponsor ID
- Goal setting in Stroke
- Conditions
- Stroke
- Keywords
- Implementation, Realist evaluation, Stroke, Improvement program, Goal setting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Federal Public Service Health, Food Chain Safety and Environment
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 23 Sep 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 3 Oct 2023 (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.
Overall objective: The aim of the project is to integrate the quality improvement programme on goal setting into the current care of people with stroke and to test and refine this programme.
Target group:
- People after a stroke (treatment in the participating centres); total number 155 people
- Informal carers (only if the person has had a stroke and has limited opportunities to participate)
- Professional carer; total number 155 people
What?
The goal-setting programme becomes standard care, it is checked whether the programme has been applied in care by health professionals (review of the patient's medical record), what the effects are on patients (questionnaires) and health professionals (questionnaires) and whether the quality improvement programme needs to be adjusted or refined (interviews with health professionals and the patient group)
When to evaluate?
- Health professionals: start of the study and end of the study via questionnaires. Interviews/focus group (every 3 months)
- Review of patient records and observations (every 3 weeks)
- Patient assessment: Admission and 1 week before discharge or end of study, Interviews/focus group (3 months)
Detailed description
Aim This study aims to evaluate the implementation of a quality improvement program to improve goal-setting in the rehabilitation process after a stroke event (further referred to as goal-setting programme) by means of a realist evaluation.
During this project, following questions will be answered:
What are the different elements and the final form of the initial goal-setting programme? How is goal-setting for the implementation of the goal-setting programme conducted? How is the goal-setting programme implemented? Is the goal-setting programme accepted, is it appropriate and feasible to implement? (review the implementation process).
Are adjustments needed on the goal-setting programme? How are the adjustments in the goal-setting programme being followed up? (review the implementation process) Does the implementation of the goal-setting programme in healthcare have an effect for patient or professional healthcare providers? (patient and healthcare professional outcome: Satisfaction with stroke care, participation, emotional status, empowerment and quality of life and overall feeling on goal-setting in stroke care)
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People after a stroke event | Experimental | Procedure: Goal setting improvement programImplementation of improvement program |
| Healthcare professionals | Experimental | Procedure: Goal setting improvement programImplementation of improvement program |
| Close relatives of people after a stroke | Experimental | Procedure: Goal setting improvement programImplementation of improvement program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants are employed in hospitals, rehabilitation centres and/or private practices/primary healthcare facilities located in the provinces: Province of Flemish Brabant, Brussels, Province of Walloon Brabant, Limburg
- Participants have a social, medical profession/background, work in the management of healthcare services or quality of healthcare
- Participants involved (direct or indirect) in the goal-setting process of the patients
- Participants who master the Flemish or French language
- Adult participants (≥18 years)
Key exclusion criteria (5 listed)
- Not giving informed consent
- Patients
- Not giving informed consent
- Other severe comorbidities that interfere with the rehabilitation process or goal-setting process
- Informal caregivers
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 |
|---|---|---|
| Goal setting improvement programA improvement program how to optimalize patient-centered goal setting in rehab care is being implemented. | Procedure or surgery | Close relatives of people after a stroke, Healthcare professionals, People after a stroke event |
Primary outcome
Adoption and adherence of goal-setting programme- in acute care setting
Time frame: Once up to 3 weeks during the hospitalisation period, through study completion, an average of 1 year
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
Adoption and adherence of goal-setting programme- in rehabilitation setting
Time frame: Every 3 weeks during the hospitalisation period, through study completion, an average of 1 year
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
10 secondary outcomes
Evaluation of patient/ informal caregivers: Measuring patient satisfaction with stroke care
Time frame: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers: Patient Participation
Time frame: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, Patient empowerment:
Time frame: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, Level of depression:
Time frame: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, general Self-Efficacy
Time frame: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of patient/ informal caregivers, stroke self-efficacy:
Time frame: Baseline and immediately after the intervention/admission to the healthcare institution
Evaluation of professional healthcare providers: Satisfaction of employees in healthcare
Time frame: Baseline and immediately after the intervention
Evaluation of professional healthcare providers; Self- efficacy
Time frame: Baseline and immediately after the intervention
Evaluation of professional healthcare providers; Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure questionnaire
Time frame: 1-2 months after study start, at 4 months after study start and immediately after the intervention
Feedback on the goal setting programme and implementation strategies.
Time frame: 2-3, 5 and 8 months after study start.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- 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.
Annemie Spooren, prof dr principal investigator
UHasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal setting improvement program in people with Stroke, run by Hasselt University at 1 site in Belgium.
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 10 inclusion and 5 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 3 Oct 2023. 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 Belgium. 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?
Contact Annemie Spooren, prof dr (+3211269332, annemie.spooren@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption and adherence of goal-setting programme- in acute care setting (time frame: Once up to 3 weeks during the hospitalisation period, through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2023.