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Completed

NCT Number: NCT05646589

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?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aleris Dalengeriatriken, Stockholm, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Regular care transition

Behavioral

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

Primary outcomes

  1. Care Transition Measure

    Time frame: 1 week after discharge from hospital

    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

Secondary outcomes

  1. The Medication Adherence Report Scale (patient)

    Time frame: 1 week, 3 and 12 months after inclusion

    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.

  2. General Person-centred Care Questionnaire

    Time frame: 1 week, 3 and 12 months after inclusion

    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

  3. Stroke Impact Scale, perceived recovery (patient)

    Time frame: inclusion, 1 week, 3 and 12 months after inclusion

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

  4. Stroke Patient Education Retention

    Time frame: 1 week, 3 and 12 months after inclusion

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

  5. EuroQol 5D

    Time frame: 1 week and 12 months after inclusion

    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"

  6. Health Literacy Survey

    Time frame: 1 week, 3 and 12 months after inclusion

    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

  7. Satisfaction with care and rehabilitation

    Time frame: 1 week, 3 and 12 months after inclusion

    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

  8. General Self-Efficacy Scale

    Time frame: 12 months after inclusion

    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)

  9. Caregiver Burden Scale (significant other)

    Time frame: 3 months after inclusion

    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.

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

    Time frame: 3 months after inclusion

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

  11. EuroQol 5D (significant other)

    Time frame: 3 months after inclusion

    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"

  12. Health Literacy Questionnaire

    Time frame: 1 week, 3 and 12 months after inclusion

    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.

Other outcomes

  1. Patient Health Questionnaire-2

    Time frame: inclusion, 1 week, 3 and 12 months after inclusion

    Questionnaire with to items that inquire about the frequency of depressed mood and anhedonia over the past two weeks. Score ranges from 0 (not at all) to 6 (nearly every day)

  2. Fatigue visual analogue scale

    Time frame: inclusion, 1 week, 3 and 12 months after inclusion

    A visual analogue scale ranging from 0 (no fatigue) to 100 (extreme fatigue)

  3. Barthel Index

    Time frame: inclusion, 1 week, 3 and 12 months after inclusion

    Questionnaire that includes 10 personal care and mobility activities, each scoring 0, 5 or 10 points resulting in a total score of 0 to 100, where a higher score reflects a greater degree of independence.

  4. Modified Rankin Scale

    Time frame: 1 week, 3 and 12 months after inclusion

    Assesses degree of disability. Scores range from 0 (no disability) to 6 (death)

  5. Montreal Cognitive Assessment Scale

    Time frame: inclusion, 3 and 12 months after inclusion

    Questionnaire assessing cognitive function. The scores range from 1 to 15 where 15 represents no cognitive impairment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Forte

Registry information

Official study title

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

Acronym: Missing Link

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 12, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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