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StrokeMissing LinkNCT02925871

The Missing Link- Development and Feasibility Evaluation of Person-centred Transitions From the Stroke Unit to the Home

A study testing Co-designed person-centred care transitions and Current care transitions in people with Stroke, run by Karolinska Institutet at 2 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Co-designed person-centred care transitions and Current care transitions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesSweden
Study dates
Apr 2016to 7 Dec 2022
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 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites
  • Karolinska University Hospital

    Huddinge

  • Danderyd hospital

    Stockholm, 18288

Other trials in Sweden

About this study

Official title: The Missing Link- Development and Feasibility Evaluation of Person-centred Transitions From the Stroke Unit to the Home - a Co-design Project

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.

Read the detailed description

A phased approach, as recommended for development and evaluation of complex interventions, will be used. In phase 1 the current transitions from stroke units to the home environment will be explored and facilitators / barriers to coordinated person-centred safe transitions will be identified. Knowledge generated in phase 1 will inform phase 2; a co-design process of new coordinated person-centred car transitions conducted by people with stroke, significant others and staff from stroke units and interdisciplinary home rehabilitation teams together. Knowledge from phase 1 and phase 2 will inform phase 3; implementation and feasibility evaluation of the new care transitions.

Phase 1 Aims: Explore current state of care transitions combined with rehabilitation in the home, identify facilitators and barriers to person-centred transitions, current patient and caregiver outcome, satisfaction, and resource use of health services during the first year after stroke.

Design: prospective longitudinal observational study.

  1. Participants: people with mild/moderate stroke, referred from stroke units to home rehabilitation and their significant others will be asked to participate before discharge from the stroke unit. Data collection: Baseline data on medical and socio-demographic aspects and functioning will be collected from the medical records. Data on satisfaction with the transition process will be collected after discharge from the stroke unit. At 3, and 12 months people with stroke will be assessed regarding disability, perceived impact of stroke, participation in social activities, health related quality of life, perceived needs of health services and satisfaction with services received using reliable validated measures and structured interviews. Data on caregiver burden, life satisfaction and informal care will be collected from significant others. Data on use of health care will be obtained from the register at Region Stockholm. Analyses: Statistical analyses to identify factors at baseline associated with satisfactory transitions, and associations between perceived quality of transitions and patient and significant other outcomes at 3 and 12 months.
  2. Participants: staff of stroke units and interdisciplinary home rehabilitation teams. Data collection: Focus group interviews with staff of stroke units on experiences of identifying candidates for home rehabilitation, the planning and decisions; and with the interdisciplinary teams on experiences of preparation for rehabilitation in the home and establishing new contacts with people referred for home rehabilitation. Analyses: Grounded theory.
  3. Participants: Strategic samples of people with stroke based on satisfaction with transition and their significant others.

Data collection: Semistructured individual interviews on the experiences of the transition from the stroke unit to the home and the initiation of the home rehabilitation.

Analyses: Grounded theory.

Phase 2 Aims: Develop new person-centred coordinated transitions. Design: Workshops with all stakeholders using a collaborative design process which include reflection, analysis, and description of the problem, visualization to get a common picture, modelling and/or prototyping.

Participants: People with stroke, significant others, staff from stroke units and interdisciplinary home rehabilitation teams in a series of five workshops.

Data collection: field-notes, diaries and documentation of the design process.

Phase 3 Aims: Implement and evaluate the new person-centred transitions between stroke units and the home in a feasibility study regarding satisfaction with the transitions, patient and caregiver outcomes and use of health care during the first year after stroke and explore experiences of the new transitions from all stakeholders involved.

  1. Design: cluster non-randomized controlled feasibility study. Participants: people with mild/moderate stroke, referred from stroke units to home rehabilitation and their significant others will be asked to participate before discharge from the stroke unit. The intervention will be implemented at a geriatric stroke unit and an acute stroke unit at Danderyd Hospital and two corresponding home rehabilitatin teams in Stockholm, Sweden. The controls will be recruited from an acute stroke unit at Karolinska University Hospital in Stockholm, Sweden. In total, 50 persons will be consecutively included, 25 from the intervention site and 25 from the control site. In addition, staff of the participating stroke units and interdisciplinary teams will be recruited.

Data collection: Data on feasibility, operationalised as fidelity and acceptability, of the intervention will be collected by participant observations, interviews, and data from the healthcare record. Data on likely effectiveness will be collected using questionnaires and registry data:

  1. Sociodemographic and disease-related data will be collected from hospital records and cognitive function, depression, and fatigue in structured interviews. One week after discharge data will be collected on the primary outcome satisfaction with the transition process, and the secondary outcomes patient health literacy, medication adherence, fatigue, depresion symptoms. At 3 months, data will be collected on health literacy, medication adherence, fatigue, depresion symptoms, self-efficacy, perceived stroke recovery, activities of daily living, and satisfaction with care. All data will be collected using validated questionnaires.
  2. Semi-structured interviews will be held with a purposive sampling of about 10 patients, and about 10 healthcare professionals. For people with stroke, the interviews will be conducted one-week after discharge. For professionals, the interviews will be conducted 1 to 3 months after start of intervention.
  3. Analyses: Patients in the intervention group will be compared to control group using intention-to-treat analysis.
  4. Analyses: Qualitative content analysis
Conditions
Stroke
Being tested
Co-designed person-centred care transitions, Current care transitions
Keywords
stroke, rehabilitation, interdisciplinary health team, patient-centered care, care transition
Medical subject headings
Stroke

What participants receive

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

  • Co-designed person-centred care transitionsBehavioural

    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.

  • Current care transitionsBehavioural

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

Study groups in NCT02925871
Study groupRoleWhat they receive
Co-designed person-centred care transitionsExperimentalCo-designed person-centred care transitions from stroke unit to rehabilitation in the home
Receives: Behavioral: Co-designed person-centred care transitions
Current care transitionsActive comparatorCurrent care transitions from the stroke unit to rehabilitation in the home
Receives: Behavioral: Current care transitions

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 stroke unit

Secondary outcomes (7)
  1. 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 and 3 months after inclusion

  2. 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: 1 week and 3 months after inclusion

  3. 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 and 3 months after inclusion

  4. General Self-Efficacy Scale (patient)

    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") where higher scores indicate higher self-efficacy.

    Measured: 3 months after inclusion

  5. 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

  6. EuroQol-5D Visual Analogue Scale (significant other)

    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: 3 months after inclusion

  7. 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) where higher scores indicate a higher satisfaction.

    Measured: 3 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 posted6 Oct 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion7 Dec 2022
  4. Study completion7 Dec 2022

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925871
Sponsor's protocol ID
2015/1923-31/2
Acronym
Missing Link
Status last verified
Mar 2026
First submitted
8 Apr 2016
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, 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, 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
  • 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, 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, 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
  • 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
  • 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
  • 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, 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, 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
  • Malstam E, Ytterberg C, Flink M, Tistad M, Stenfors T, von Koch L, Lindblom S. Learning Teach-Back in clinical practice: a qualitative study of healthcare professionals. BMC Med Educ. 2026 Sep 7;26(1):1432. doi: 10.1186/s12909-026-10315-6.

    PubMed 42706547

Questions about this trial

What is this clinical trial studying?

A study testing Co-designed person-centred care transitions and Current care transitions in people with Stroke, run by Karolinska Institutet at 2 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 2 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 stroke unit). 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 NCT02925871, 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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