Missing Link: A Person-centred Care Transition Support for People With Stroke/TIA
Study Details
Study Description
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:
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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?
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What are the experiences of the intervention components and the implementation process?
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How does the intervention get adapted and implemented in practice?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Person-centred care transition support
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Behavioral: Person-centred care transition support
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
|
| Active Comparator: Regular care transition
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Behavioral: Regular care transition
Regular care transitions, initiated by an electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team
|
Outcome Measures
Primary Outcome Measures
- Care Transition Measure [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 Outcome Measures
- The Medication Adherence Report Scale (patient) [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.
- General Person-centred Care Questionnaire [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
- Stroke Impact Scale, perceived recovery (patient) [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)
- Stroke Patient Education Retention [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
- EuroQol 5D [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"
- Health Literacy Survey [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
- Satisfaction with care and rehabilitation [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
- General Self-Efficacy Scale [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)
- Caregiver Burden Scale (significant other) [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.
- Life Satisfaction Checklist, item 1 (significant other) [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)
- EuroQol 5D (significant other) [3 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 (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"
- Health Literacy Questionnaire [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 Outcome Measures
- Patient Health Questionnaire-2 [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)
- Fatigue visual analogue scale [inclusion, 1 week, 3 and 12 months after inclusion]
A visual analogue scale ranging from 0 (no fatigue) to 100 (extreme fatigue)
- Barthel Index [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.
- Modified Rankin Scale [1 week, 3 and 12 months after inclusion]
Assesses degree of disability. Scores range from 0 (no disability) to 6 (death)
- Montreal Cognitive Assessment Scale [inclusion, 3 and 12 months after inclusion]
Questionnaire assessing cognitive function. The scores range from 1 to 15 where 15 represents no cognitive impairment
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aleris Dalengeriatriken | Stockholm | Sweden | ||
| 2 | Danderyd hospital | Stockholm | Sweden | ||
| 3 | Södersjukhuset | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska Institutet
- Forte
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-02105-01