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Preventing the next stroke – nurse-led decision and adherence coaching to empower people with stroke (StrokeCompass): study protocol for a stepped wedge pilot trial

Preventing the next stroke – nurse-led decision and adherence coaching to empower people with stroke (StrokeCompass): study protocol for a stepped wedge pilot trial - StrokeCompass

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036091
Enrollment
452
Registered
2025-03-06
Start date
2025-04-22
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD-10: I63 (Cerebral infarction/Ischemic stroke), I64 (Stroke, not specified as hemorrhage or infarction) G45 I63 I64

Interventions

Group 1: Intervention: Nurse-led decision and adherence coaching with a web-based patient decision aid
Physician’s consultation with goal setting Group 2: Control: Optimised standard care with an informational brochure and a short nurse-led conversation

Sponsors

Universität zu Lübeck
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) First ischaemic stroke (clinical diagnosis) or first transient ischaemic attack (TIA), ABCD2 score = 3. 2) Affected people feel physically and mentally able to participate in the study. 3) Willingness to participate in the study and written informed consent. 4) Affected people have access to the Internet at home.

Exclusion criteria

Exclusion criteria: 1) The NIHSS must not be greater than 0 in items 1a-c (vigilance, orientation, following prompts) . 2) Patient is unable to grasp the information material with sufficient certainty / participate appropriately in coaching due to eye movement disorders or visual impairment 3) Communication limitations due to aphasia or language barriers of a severity that prevent the comprehension of information material/participation in coaching 4) Stroke aetiology with differing secondary prevention: e.g. coagulation disorders (hereditary or paraneoplastic), dissection of a vessel, vasculitis (autoimmune or parainfectious), peri-interventional / perioperative strokes / TIAs, presence of symptomatic stenoses of the vessels supplying the brain (both intracranial and extracranial). 5) Severe cognitive impairments and known dementia. 6) Participation in another clinical trial with a competing intervention (e.g. specialized aftercare, extended secondary prevention).

Design outcomes

Primary

MeasureTime frame
Evaluation of feasibility and acceptance Adherence to stroke prevention medication, measured by achieving guideline-based therapy target values after 12 months (LDL cholesterol and blood pressure levels)

Secondary

MeasureTime frame
1. Health status of participants 2. Adherence 3. Number of recurrent strokes 4. Participants’ knowledge of stroke 5. The potential of the expanded nursing role in improving patient empowerment 6. Involvement of participants in the decision-making process 7. Economic evaluation of the intervention 8. Barriers and facilitators for the implementation of the intervention

Countries

Germany

Contacts

Public ContactAnne-Christin Rahn

Universität zu Lübeck

AnneChristin.Rahn@uksh.de0049451 500-51261

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 1, 2026