NCT02925871

Brief Summary

The aim is to design, implement and evaluate new person-centred transitions between stroke units and the home. The development of person-centred transition will be performed together by people with stroke, significant others, stroke unit staff and interdisciplinary teams. Phase 1, a prospective observational study of current transitions from stroke units to rehabilitation in the home without coordination. The aim is to identify factors that are facilitators or barriers to transitions, patient and caregiver outcomes, use of health care during the first year after stroke. In phase 2, a co-design process of new person-centred transitions will be carried out by people with stroke, significant others, stroke unit staff and interdisciplinary home rehabilitation teams. In phase 3 new person-centred transitions will be implemented and evaluated in a feasibility study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

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

April 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6.7 years

First QC Date

April 8, 2016

Last Update Submit

March 24, 2026

Conditions

Keywords

strokerehabilitationinterdisciplinary health teampatient-centered carecare transition

Outcome Measures

Primary Outcomes (1)

  • Care Transition Measure

    Questionnaire that assesses perceived quality in care transitions. The total score (0-100) reflects the overall perceived quality of the care transition, with lower scores indicating a poor quality care transition, and higher scores indicating a higher quality care transition.

    1 week after discharge from hospital stroke unit

Secondary Outcomes (7)

  • Health Literacy Questionnaire

    1 week and 3 months after inclusion

  • Stroke Impact Scale, perceived recovery (patient)

    1 week and 3 months after inclusion

  • The Medication Adherence Report Scale (patient)

    1 week and 3 months after inclusion

  • General Self-Efficacy Scale (patient)

    3 months after inclusion

  • Caregiver Burden Scale (significant other)

    3 months after inclusion

  • +2 more secondary outcomes

Other Outcomes (3)

  • Fatigue visual analogue scale (patient)

    1 week and 3 months after inclusion

  • Patient Health Questionnaire-2 (patient)

    1 week and 3 months after inclusion

  • Barthel Index (patient)

    1 week and 3 months after inclusion

Study Arms (2)

Co-designed person-centred care transitions

EXPERIMENTAL

Co-designed person-centred care transitions from stroke unit to rehabilitation in the home

Behavioral: Co-designed person-centred care transitions

Current care transitions

ACTIVE COMPARATOR

Current care transitions from the stroke unit to rehabilitation in the home

Behavioral: Current care transitions

Interventions

The intervention consists of several elements that aim to meet patients', significant others', and professionals' needs for shared understanding, patient preparedness for homecoming, and coordination.

Co-designed person-centred care transitions

Control group participants will receive current care transitions, initiated by an electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team

Current care transitions

Eligibility Criteria

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

You may qualify if:

  • patients who have had a first time or recurrent stroke, and who will be discharged home from the participating stroke units and referred to a rehabilitation team in primary healthcare for continued rehabilitation in the home.

You may not qualify if:

  • unable to give informed consent, due to e.g., severe aphasia or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska University Hospital

Huddinge, Sweden

Location

Danderyd hospital

Stockholm, 18288, Sweden

Location

Related Publications (10)

  • Flink M, Lindblom S, Tistad M, Laska AC, Bertilsson BC, Warlinge C, Hasselstrom J, Elf M, von Koch L, Ytterberg C. Person-centred care transitions for people with stroke: study protocol for a feasibility evaluation of codesigned care transition support. BMJ Open. 2021 Dec 23;11(12):e047329. doi: 10.1136/bmjopen-2020-047329.

    PMID: 34949604BACKGROUND
  • Lindblom S, Ytterberg C, Elf M, Flink M. Perceptive Dialogue for Linking Stakeholders and Units During Care Transitions - A Qualitative Study of People with Stroke, Significant Others and Healthcare Professionals in Sweden. Int J Integr Care. 2020 Mar 25;20(1):11. doi: 10.5334/ijic.4689.

  • Lindblom S, Flink M, Sjostrand C, Laska AC, von Koch L, Ytterberg C. Perceived Quality of Care Transitions between Hospital and the Home in People with Stroke. J Am Med Dir Assoc. 2020 Dec;21(12):1885-1892. doi: 10.1016/j.jamda.2020.06.042. Epub 2020 Jul 29.

  • Lindblom S, Flink M, Elf M, Laska AC, von Koch L, Ytterberg C. The manifestation of participation within a co-design process involving patients, significant others and health-care professionals. Health Expect. 2021 Jun;24(3):905-916. doi: 10.1111/hex.13233. Epub 2021 Mar 17.

  • Lindblom S, Tistad M, Flink M, Laska AC, von Koch L, Ytterberg C. Referral-based transition to subsequent rehabilitation at home after stroke: one-year outcomes and use of healthcare services. BMC Health Serv Res. 2022 May 3;22(1):594. doi: 10.1186/s12913-022-08000-7.

  • Lindblom S, Ytterberg C, Flink M, Carlsson AC, Stenberg U, Tistad M, von Koch L, Laska AC. The Use of Teach Back at Hospital Discharge to Support Self-Management of Prescribed Medication for Secondary Prevention after Stroke-Findings from A Feasibility Study. Healthcare (Basel). 2023 Jan 30;11(3):391. doi: 10.3390/healthcare11030391.

  • Flink M, Lindblom S, von Koch L, Carlsson AC, Ytterberg C. Health literacy is associated with less depression symptoms, higher perceived recovery, higher perceived participation, and walking ability one year after stroke - a cross-sectional study. Top Stroke Rehabil. 2023 Dec;30(8):865-871. doi: 10.1080/10749357.2023.2178133. Epub 2023 Feb 21.

  • Hess Engstrom A, Flink M, Lindblom S, von Koch L, Ytterberg C. Association between general self-efficacy and health literacy among stroke survivors 1-year post-discharge: a cross-sectional study. Sci Rep. 2024 Mar 27;14(1):7308. doi: 10.1038/s41598-024-57738-z.

  • Lindblom S, Flink M, von Koch L, Laska AC, Ytterberg C. Feasibility, Fidelity and Acceptability of a Person-Centred Care Transition Support Intervention for Stroke Survivors: A Non-Randomised Controlled Study. Health Expect. 2024 Oct;27(5):e70057. doi: 10.1111/hex.70057.

  • Hess Engstrom A, Lindblom S, Flink M, Soderberg S, von Koch L, Ytterberg C. Stroke survivors' health literacy is not associated with caregiver burden: a cross-sectional study. Sci Rep. 2025 Feb 8;15(1):4720. doi: 10.1038/s41598-025-89523-x.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Charlotte Ytterberg, PhD

    Karolinska Institutet, Department of Neurobiology, Care Sciences and Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor (docent)

Study Record Dates

First Submitted

April 8, 2016

First Posted

October 6, 2016

Study Start

April 1, 2016

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results in a publication, after deidentification.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Immediately following publication and ending two years after publication
Access Criteria
Since data can indirectly be traced back to the study participants, according to the Swedish and EU personal data sharing legislation, access can only be granted upon request. Request for access to the data can be put to our Research Data Office (rdo@ki.se) at Karolinska Institutet, and will be handled according to the relevant legislation. In most cases, this will require a data processing agreement or similar with the recipient of the data.

Locations