NCT06065397

Brief 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. 1.People after a stroke (treatment in the participating centres); total number 155 people
  2. 2.Informal carers (only if the person has had a stroke and has limited opportunities to participate)
  3. 3.Professional carer; total number 155 people
  4. 4.Health professionals: start of the study and end of the study via questionnaires. Interviews/focus group (every 3 months)
  5. 5.Review of patient records and observations (every 3 weeks)
  6. 6.Patient assessment: Admission and 1 week before discharge or end of study, Interviews/focus group (3 months)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

February 28, 2023

Last Update Submit

October 2, 2023

Conditions

Keywords

ImplementationRealist evaluationStrokeImprovement programGoal setting

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    Baseline and immediately after the intervention/admission to the healthcare institution

  • Evaluation of patient/ informal caregivers: Patient Participation

    Baseline and immediately after the intervention/admission to the healthcare institution

  • Evaluation of patient/ informal caregivers, Patient empowerment:

    Baseline and immediately after the intervention/admission to the healthcare institution

  • Evaluation of patient/ informal caregivers, Level of depression:

    Baseline and immediately after the intervention/admission to the healthcare institution

  • Evaluation of patient/ informal caregivers, general Self-Efficacy

    Baseline and immediately after the intervention/admission to the healthcare institution

  • +5 more secondary outcomes

Study Arms (3)

People after a stroke event

EXPERIMENTAL

Implementation of improvement program

Procedure: Goal setting improvement program

Healthcare professionals

EXPERIMENTAL

Implementation of improvement program

Procedure: Goal setting improvement program

Close relatives of people after a stroke

EXPERIMENTAL

Implementation of improvement program

Procedure: Goal setting improvement program

Interventions

A improvement program how to optimalize patient-centered goal setting in rehab care is being implemented.

Close relatives of people after a strokeHealthcare professionalsPeople after a stroke event

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Not giving informed consent
  • Patients
  • Participants after a stroke event.
  • 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)
  • Not giving informed consent
  • Other severe comorbidities that interfere with the rehabilitation process or goal-setting process
  • Informal caregivers
  • Informal caregiver of a stroke patient admitted to one of the four participating sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHasselt

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Annemie Spooren, prof dr

    UHasselt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemie Spooren, prof dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

February 28, 2023

First Posted

October 3, 2023

Study Start

January 17, 2023

Primary Completion

September 23, 2023

Study Completion

March 30, 2024

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations