A Person-centred Care Transition Support for People With Stroke/TIA (Missing Link)
Primary Purpose
Stroke, Transient Ischemic Attack
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Person-centred care transition support
Regular care transition
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
Eligibility 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.
Sites / Locations
- Aleris DalengeriatrikenRecruiting
- Danderyd hospital
- Södersjukhuset
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Person-centred care transition support
Regular care transition
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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)
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
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"
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
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
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)
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.
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)
EuroQol 5D (significant other)
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
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.
Full Information
NCT ID
NCT05646589
First Posted
December 2, 2022
Last Updated
December 9, 2022
Sponsor
Karolinska Institutet
Collaborators
Forte
1. Study Identification
Unique Protocol Identification Number
NCT05646589
Brief Title
A Person-centred Care Transition Support for People With Stroke/TIA
Acronym
Missing Link
Official Title
Implementation and Evaluation of a Person-centred Care Transition Support for People With Stroke/TIA
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Forte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
336 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Person-centred care transition support
Arm Type
Experimental
Arm Title
Regular care transition
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Person-centred care transition support
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Regular care transition
Intervention Description
Regular care transitions, initiated by an electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team
Primary Outcome Measure Information:
Title
Care Transition Measure
Description
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
Time Frame
1 week after discharge from hospital
Secondary Outcome Measure Information:
Title
The Medication Adherence Report Scale (patient)
Description
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.
Time Frame
1 week, 3 and 12 months after inclusion
Title
General Person-centred Care Questionnaire
Description
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
Time Frame
1 week, 3 and 12 months after inclusion
Title
Stroke Impact Scale, perceived recovery (patient)
Description
Perceived recovery after stroke is rated on a visual analogue scale ranging from 0 (no recovery) to 100 (full recovery)
Time Frame
inclusion, 1 week, 3 and 12 months after inclusion
Title
Stroke Patient Education Retention
Description
Questionnaire with five questions. scores range from 0 to 10 where a higher score represents a higher comprehension and retention of poststroke care education
Time Frame
1 week, 3 and 12 months after inclusion
Title
EuroQol 5D
Description
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"
Time Frame
1 week and 12 months after inclusion
Title
Health Literacy Survey
Description
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
Time Frame
1 week, 3 and 12 months after inclusion
Title
Satisfaction with care and rehabilitation
Description
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
Time Frame
1 week, 3 and 12 months after inclusion
Title
General Self-Efficacy Scale
Description
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)
Time Frame
12 months after inclusion
Title
Caregiver Burden Scale (significant other)
Description
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.
Time Frame
3 months after inclusion
Title
Life Satisfaction Checklist, item 1 (significant other)
Description
Questionnaire that assesses life satisfaction with one global item "Life as a whole". Answering alternatives range from 1 (very dissatisfied) to 6 (very satisfied)
Time Frame
3 months after inclusion
Title
EuroQol 5D (significant other)
Description
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"
Time Frame
3 months after inclusion
Title
Health Literacy Questionnaire
Description
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.
Time Frame
1 week, 3 and 12 months after inclusion
Other Pre-specified Outcome Measures:
Title
Patient Health Questionnaire-2
Description
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)
Time Frame
inclusion, 1 week, 3 and 12 months after inclusion
Title
Fatigue visual analogue scale
Description
A visual analogue scale ranging from 0 (no fatigue) to 100 (extreme fatigue)
Time Frame
inclusion, 1 week, 3 and 12 months after inclusion
Title
Barthel Index
Description
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.
Time Frame
inclusion, 1 week, 3 and 12 months after inclusion
Title
Modified Rankin Scale
Description
Assesses degree of disability. Scores range from 0 (no disability) to 6 (death)
Time Frame
1 week, 3 and 12 months after inclusion
Title
Montreal Cognitive Assessment Scale
Description
Questionnaire assessing cognitive function. The scores range from 1 to 15 where 15 represents no cognitive impairment
Time Frame
inclusion, 3 and 12 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Ytterberg, PhD
Phone
+46852488882
Email
charlotte.ytterberg@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Flink, PhD
Phone
+46702788357
Email
maria.flink@ki.se
Facility Information:
Facility Name
Aleris Dalengeriatriken
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Sandberg, PhD
Email
linda.sandberg@aleris.se
Facility Name
Danderyd hospital
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann-Charlotte Laska, PhD
Email
ann-charlotte.laska@regionstockholm.se
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oana Romanitan, PhD
Email
mihaela.romanitan@regionstockholm.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Person-centred Care Transition Support for People With Stroke/TIA
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