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StrokeMissing LinkNCT05646589

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

A study testing Person-centred care transition support and Regular care transition in people with Stroke and Transient Ischemic Attack, run by Karolinska Institutet at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Transient Ischemic Attack
What is being tested?
Person-centred care transition support and Regular care transition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
3 sitesSweden
Study dates
21 Nov 2022to 15 Sep 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Aleris Dalengeriatriken

    Stockholm

  • Danderyd hospital

    Stockholm

  • Södersjukhuset

    Stockholm

Other trials in Sweden

About this study

Official title: Implementation and Evaluation of a Person-centred Care Transition Support for People With Stroke/TIA

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?
Read more

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.

Read the detailed description

Care transitions following a stroke call for integrated care approaches to reduce death and disability. The proposed research described in this study protocol aims to evaluate the ef-fectiveness of a person-centred multicomponent care transition support and the process in terms of contextual moderators, implementation aspects and mechanisms of impact.

A non-randomized controlled trial design will be used. The intervention includes 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.

Patients with stroke or TIA who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation will be included. Follow-ups will be conducted at one week, 3 months and 12 months. Data will be collected on the primary outcome of perceived quality of the care transition, and on the secondary outcomes of health literacy, medication adherence, and perceived person-centeredness. Data for process evaluation will be collected through semi-structured interviews, focus groups, partici-patory observations, and the Normalisation Measure Development Questionnaire.

Being tested
Person-centred care transition support, Regular care transition
Keywords
clinical trial, complex intervention, care transition, process evaluation, secondary prevention, hospital discharge, health literacy
Medical subject headings
Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Person-centred care transition supportBehavioural

    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

  • Regular care transitionBehavioural

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

Study groups in NCT05646589
Study groupRoleWhat they receive
Person-centred care transition supportExperimentalPerson-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.
Receives: Behavioral: Person-centred care transition support
Regular care transitionActive comparatorElectronic referral from hospital healthcare professionals to the receiving neurorehabilitation team
Receives: Behavioral: Regular care transition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 week after discharge from hospital

Secondary outcomes (12)

  1. The Medication Adherence Report Scale (patient)

    Questionnaire that consists of 5 items that assesses medication adherence. Participants are asked to rate the frequency with which they engaged in each of the adherence-related behaviours on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item were summed to give a total score, with higher scores indicating higher levels of reported adherence.

    Measured: 1 week, 3 and 12 months after inclusion

  2. General Person-centred Care Questionnaire

    Questionnaire with 21 questions about experiences of care and treatment. Responses are graded on a five-point Likert scale where a higher score represents a more person-centred experience i.e., a better outcome

    Measured: 1 week, 3 and 12 months after inclusion

  3. Stroke Impact Scale, perceived recovery (patient)

    Perceived recovery after stroke is rated on a visual analogue scale ranging from 0 (no recovery) to 100 (full recovery)

    Measured: inclusion, 1 week, 3 and 12 months after inclusion

  4. Stroke Patient Education Retention

    Questionnaire with five questions. scores range from 0 to 10 where a higher score represents a higher comprehension and retention of poststroke care education

    Measured: 1 week, 3 and 12 months after inclusion

  5. EuroQol 5D

    EuroQol 5D, consists of the EQ-5D Index and the EQ Visual Analog Scale. The EuroQol 5D comprises 5 pre-defined dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. The respondent rates each dimension on a three level scale as having no problem, a moderate problem or a severe problem. The answers are then converted to an index value (the EQ Index) ranging from 0 (representing death) to 1 (full health). The EQ VAS records the respondent's self-rated health on a 20-centimeter vertical visual analog scale with end-points ranging from 0 to 100. The single global question in the EQ VAS asks the individual to label his/her health as "the worst health you can imagine" (0) to "the best health you can imagine"

    Measured: 1 week and 12 months after inclusion

  6. Health Literacy Survey

    Questionnaire comprising 16 items focusing on four dimensions: ability to access/obtain health information, understand health information, ability to process/appraise health information, and ability to apply/use health information. Score ranges from 0-16 where a higher score represents a higher health literacy

    Measured: 1 week, 3 and 12 months after inclusion

  7. Satisfaction with care and rehabilitation

    Questionnaire with two questions. The respondent is asked to disagree or disagree with two statements on a Likert scale from 1 to 5 where a higher score represents higher satisfaction with care and rehabilitation

    Measured: 1 week, 3 and 12 months after inclusion

  8. General Self-Efficacy Scale

    Questionnaire that assesses the strength of an individual's belief in his/her own ability to respond to novel or difficult situations and to deal with any associated obstacles or setbacks. The scale consists of 10 items rated on a four-point Likert scale ("not at all true" to "exactly true"). Means are calculated as the sum of all answers divided by ten (i.e., the total number of items)

    Measured: 12 months after inclusion

  9. Caregiver Burden Scale (significant other)

    Questionnaire that consists of 22 items for different types of subjective caregiver burden, covering areas of the caregiver's health, feelings of psychological well-being, relations, social network, physical workload, and environmental aspects. The items are scored on a scale from 1 to 4 and the higher the score the greater the burden.

    Measured: 3 months after inclusion

  10. Life Satisfaction Checklist, item 1 (significant other)

    Questionnaire that assesses life satisfaction with one global item "Life as a whole". Answering alternatives range from 1 (very dissatisfied) to 6 (very satisfied)

    Measured: 3 months after inclusion

  11. EuroQol 5D (significant other)

    Questionnaire consisting of the EQ-5D Index and the EQ Visual Analogue Scale. The EuroQol 5D-5L comprises five pre-defined dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. The respondent rates each dimension on a five level scale as having no problem, slight problems, moderate problem, severe problem, unable or extreme. The answers are then converted to an index value (the EQ Index) ranging from 0 (representing death) to 1 (full health). The EQ VAS records the respondent's self-rated health on a 20-centimeter vertical visual analo,g scale with end-points ranging from 0 to 100. The single global question in the EQ VAS asks the individual to label his/her health as "the worst health you can imagine" (0) to "the best health you can imagine"

    Measured: 3 months after inclusion

  12. Health Literacy Questionnaire

    Questionnaire that assesses health literacy. The Health Literacy Questionnaire contains 44 items, which are divided into nine areas of health literacy. The first five scales are scored on a 4-point Likert scale (ranging from strongly disagree to disagree, agree, and strongly agree), building part I. The other four scales, representing part II, are scored on a 5-point Likert scale where respondents are asked to rate the level of difficulty in undertaking a task (ranging from cannot do, always difficult, usually difficult, sometime difficult, usually easy, and always easy). Higher scores indicate better health literacy.

    Measured: 1 week, 3 and 12 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2022
  2. Study start21 Nov 2022
  3. Primary completion27 Oct 2024
  4. Study completion15 Sep 2025

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05646589
Sponsor's protocol ID
2022-02105-01
Acronym
Missing Link
Status last verified
Mar 2026
First submitted
2 Dec 2022
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results in a publication, after deidentification.

Publications

  • 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.

    PubMed 36803670

  • 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.

    PubMed 36766966

  • 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.

    PubMed 35505404

  • 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.

    PubMed 34949604

  • 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.

    PubMed 33729653

  • 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.

    PubMed 32739283

  • 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.

    PubMed 32256255

  • 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.

    PubMed 39922929

  • 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.

    PubMed 39373138

  • 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.

    PubMed 38538651

  • 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.

    PubMed 38483869

Questions about this trial

What is this clinical trial studying?

A study testing Person-centred care transition support and Regular care transition in people with Stroke and Transient Ischemic Attack, run by Karolinska Institutet at 3 sites in Sweden.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Care Transition Measure (time frame: 1 week after discharge from hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05646589, which also lists 11 linked publications.

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 27 Mar 2026.

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