A Person-centred Care Transition Support for People With Stroke/TIA

NCT05646589 | Completed DMC

• 1 other identifier: 2022-02105-01
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to test a person-centred care transition support in people with stroke/TIA. The main questions it aims to answer are:

• Does a multi-component care transition intervention have an effect on perceived quality of care transitions, health literacy, collected medications, medication adherence, perceived person-centeredness, functioning, recurrent stroke/TIA, healthcare utilization and caregiver burden?
• What are the experiences of the intervention components and the implementation process?
• How does the intervention get adapted and implemented in practice?
• What contextual moderators and mechanisms of the intervention can likely explain the potential effects of the intervention? Participants will receive a person-centred care transition support that includes a set of activities targeting how healthcare professionals can improve quality with care transition and support health literacy for self-management of secondary stroke prevention for persons who are to be discharged from hospitals after stroke or TIA. Researchers will compare participants who receive the person-centred care transition support with participants receiving regular care transitions to see if the person-centred care transition support has any effects on perceived quality of care transitions, health literacy, collected medications, medication adherence, perceived person-centeredness, functioning, recurrent stroke/TIA, healthcare utilization and caregiver burden.

Conditions

Stroke; Transient Ischemic Attack

Keywords

clinical trial; complex intervention; care transition; process evaluation; secondary prevention; hospital discharge; health literacy

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

Secondary Outcomes (12)

• The Medication Adherence Report Scale (patient)

  1 week, 3 and 12 months after inclusion

• General Person-centred Care Questionnaire

  1 week, 3 and 12 months after inclusion

• Stroke Impact Scale, perceived recovery (patient)

  inclusion, 1 week, 3 and 12 months after inclusion

• Stroke Patient Education Retention

  1 week, 3 and 12 months after inclusion

• EuroQol 5D

  1 week and 12 months after inclusion

Other Outcomes (5)

• Patient Health Questionnaire-2

  inclusion, 1 week, 3 and 12 months after inclusion

• Fatigue visual analogue scale

  inclusion, 1 week, 3 and 12 months after inclusion

• Barthel Index

  inclusion, 1 week, 3 and 12 months after inclusion

Study Arms (2)

Person-centred care transition support

EXPERIMENTAL

Person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming.

Behavioral: Person-centred care transition support

Regular care transition

ACTIVE COMPARATOR

Electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team

Behavioral: Regular care transition

Interventions

Regular care transition BEHAVIORAL

Regular care transitions, initiated by an electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team

Regular care transition

Person-centred care transition support BEHAVIORAL

Person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming.for persons who are to be discharged from hospitals after stroke or TIA

Person-centred care transition support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who have had a first time ever or recurrent stroke or TIA; who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation; and who are able to give informed consent by themselves.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Forte: collaborator

Study Sites (3)

Aleris Dalengeriatriken

Stockholm, Sweden

Location

Danderyd hospital

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Related Publications (11)

• 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.

  PMID: 36803670 BACKGROUND

• 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.

  PMID: 36766966 BACKGROUND

• 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.

  PMID: 35505404 BACKGROUND

• 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: 34949604 BACKGROUND

• 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.

  PMID: 33729653 BACKGROUND

• 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.

  PMID: 32739283 BACKGROUND

• 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.

  PMID: 32256255 BACKGROUND

• 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.

  PMID: 39922929 BACKGROUND

• 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.

  PMID: 39373138 BACKGROUND

• 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.

  PMID: 38538651 BACKGROUND

• Lindblom S, Flink M, von Koch L, Tistad M, Stenberg U, Elf M, Carlsson AC, Laska AC, Ytterberg C. A person-centred care transition support for people with stroke/TIA: A study protocol for effect and process evaluation using a non-randomised controlled design. PLoS One. 2024 Mar 14;19(3):e0299800. doi: 10.1371/journal.pone.0299800. eCollection 2024.

  PMID: 38483869 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, associate professor (docent)

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: November 21, 2022
• Primary Completion: October 27, 2024
• Study Completion: September 15, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• 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

SE (3)