The design is a randomized controlled trial with blinded assessors. The study population is the stroke patients at the Sahlgrenska stroke care unit. The Stroke unit at Sahlgrenska University Hospital serves the larger Gothenburg urban area, thus all persons from this catchment area are randomly referred to the Sahlgrenska University Hospital. The project is approved by the Regional Ethical Review Board in Gothenburg http://www.epn.se/sv/goeteborg/om-naemnden/ and the Helsinki declaration is followed. Written informed consent will be obtained from the participants or from their closest relative.
Primary outcome levels of anxiety and depression. Secondary outcomes are independence, security, level of function, quality of health, needs of support in ADL and caregiver burden.
Data entered the Riks-stroke database is used for back-ground information of each patient as well as stroke type, location, length of stay etc. Data on support and training given after discharge as well as home modifications during the first year will be gathered.
Assessments (all translated into Swedish)
Montreal Cognitive Assessment (MoCA) (
The MoCA has been proposed as a screening tool that promises good sensitivity to deficits arising from stroke and vascular cognitive impairment The MoCA includes sections on visuospatial/executive, naming, attention, language, abstraction, delayed recall, and orientation. It is scored out of 30 (extra point for <13 years' education) and the recommended “normal” cut-off is ≥26.
modified Rankin Scale (mRS) (
The mRS is used to describe overall disability. The scale runs from 0–6, running from perfect health without symptoms to death.
Fugl-Meyer sensory motor assessment (FMA) (
Fugl-Meyer Assessment, Upper (maximum score of 66 corresponds to normal motor function) and Lower extremity (maximum score of 34). The non-motor domains of FMA sensation, passive range of motion and pain during passive joint motions will be completed as well.
Figure of 8 for the hand
To assess hand volume on both hands using an ordinary tape measure (cm).
Time up and go (TUG) (
The TUG is testing basic mobility. The time (s) required for an individual to stand up from a standardized chair, walk a distance of three meters, turn, walk back to the chair and sit down again. A shorter time indicates better performance. The has been shown to be reliable and valid in this group of patients
Berg Balance Scale (BBS) (
The BBS assesses functional balance. Performance in this test is scored from 0 (cannot perform) to 4 (normal performance) on 14 different tasks, including ability to sit, stand, reach, lean over, turn around and step. The maximum score on the BBS is 56. A higher score indicates better balance skills
ADL taxonomy (
The ADL taxonomy is used for the investigation of ADL task performance and includes 12 activities. The first seven activities deal with the Personal ADL and the other five, with Instrumental ADL. During each activity are also a number of subtasks that are ranked by difficulty and can be judged on various aspects such as independence, dependent or not relevant.
Barthel index (BI) (
The BI measures the extent to which somebody can function independently and has mobility in their ADL i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Each performance item is rated on this scale with a given number of points assigned to each level. In this study the modified version with 0–100 is used, where a lower score indicates dependency.
Stroke Impact Scale (SIS) 3.0, (
Stroke Impact Scale is a questionnaire on different aspects of the stroke recovery where the person replies on their perception regarding their life after the stroke. The 59 questions are divided into 8 domains; strength, memory, emotion, communication, activities of daily living, mobility, hand function and social participation.
Impact on Autonomy and Participation, English version (IPA-E) (
IPA-E is a generic outcome measure for adults with chronic conditions where the person estimates perceived limitations in participation and autonomy related to dependency in the current living surrounding. The subscales include autonomy indoors, family role, autonomy outdoors, social life and relationships, work and education. Additionally, IPA-E identifies the extent to which limitations in life are experienced as problematic in areas of mobility, self-care, activities, economy issues, social life, work and education. IPA-E is valid, reliable and sensitive to change after stroke.
Caregiver Burden Scale (CBS) (
The CBS is a questionnaire with 22 questions (answered in written by the carer) concerning burden from the aspects of the caregiver’s health, feeling of psychological well-being, relations, social network, physical workload and environmental aspects that might be important. When the scale was developed, factor analysis was used to yield five indices – general strain (8 questions), disappointment (5 questions), isolation (3 questions), emotional involvement (3 questions) and environment (3 questions). The items are scored from 0 to 3 (Not at all, Hardly, Somewhat and Definitely), maximum score 66. (Caregiver burden could be viewed as an environmental factor)
Patient reported outcomes (not classified according to the ICF):
Hospital Anxiety and Depression Scale (HADS) (
The HADS is a 14-item questionnaire that consists of anxiety (HADS-A) and depression (HADS-D) subscales. It has good psychometric properties and is well suited for assessing symptom severity in stroke patients. A HADS-Total score of greater than 10 indicates clinically significant emotional distress.
Falls efficacy Scale (FES) (
The FES assesses perceived self-confidence in ADL-task performance without falling. It consists of 13 items including personal activities of daily living, items 1–6 and instrumental activities of daily living, items 8–13 and item 7, assessing the ability to walk up and down stairs. Confidence in performing each activity is rated on a visual numeric scale ranging from 0, not at all confident, to 10, completely confident, giving a possible maximal score of 130, and a total score of 60 for each of the two subscales.
EuroQol Quality of Life Scale (EQ-5D) (
EuroQol Quality of Life Scale is a widely used generic measure and includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D includes a visual analogue scale on which the patients rate their own health between 0 and 100.
Confirmed stroke according to WHO´s criteria
>18 years of age
Living within 30 min from the stroke unit
On day 2 National institute of health stroke scale (NIHSS) (
) of 0–16 points and BI 50–100 points.
MoCA index < 26 if BI = 100.
BI < 50
Life expectancy < 1 year (as with severe malignancy)
Does not speak or communicate in Swedish prior to the incidence
A power calculation has been performed based on the level of anxiety (assessed with the HADS) in patients at stroke units (
[27, 28]) and also what has been judged as problematic level of anxiety and long term outcome after stroke (
). The assumption is that some anxiety is normal but the aim is to reduce the risk of problematic anxiety with the intervention. With a power of 80%, p-value 0.05 (2 sided test) 44 persons per group are needed. The aim is therefore 55 persons per group, since deaths may occur as well as withdrawn consent; a total of 110. The investigation also includes data of co-morbidity, re-entry to hospital and mortality. Furthermore, data from the Swedish quality register of stroke including information of ADL function before stroke, presence of follow-up visits and questions regarding the subjective experience from the rehabilitation. Data also include information about how satisfactory the information about stroke and where to get support has been as well as the patients view concerning the sufficiency of assistance and support from home care or next of kin. Data of the amount of granted home help service from the local authority will also be collected for health economic analysis as performed by Lundström et al. (
Interviews will be accomplished with a strategic sample of 15 patients in the intervention group before discharge, within two weeks after homecoming and 3 months later to describe the patient’s subjective expectations and experiences of early discharge and rehabilitation. Interviews are also planned with a sample of about 20 relatives (caregivers) in the intervention group 3 months after discharge to describe their subjective experiences of early discharge and rehabilitation from the perspective of caregivers. In both cases, interview guides with question areas will be used. The interviews will be recorded and transcribed verbatim and further analysed with qualitative content analyses according to Krippendorff (
The planning of the home rehabilitation with the patient together with the team will be studied to analyse possibilities and/or obstacles for patient participation and activity in this process. Data will be gathered by digital audio recording of 10 planning meetings and note-taking and analysed with qualitative content analyses.
Further, observation through participation will be used to study the interaction between the patient and the team when the person is at home and how the patient participates in the rehabilitation. Data will be gathered by video recording and note-taking and analysed with both a quantitative and a qualitative approach.
Time schedule of data gathering
Day 2: (36–60 hours)
BI and MoCA performed by the occupational therapist
Day 4: (+/− 1 day)
Information about the study and randomization after informed consent
Demographic data will be collected during the first assessment. Stroke subtype will be confirmed by imaging. Ischemic strokes will be classified for subtype and site for lesion by using TOAST and Bamford classifications(
). Treatments of thrombolysis or thrombectomy will be registered. Additional data will be extracted from the national quality register for stroke - Swedish Stroke Register.
Day 5: (+/− 1 day)
Assessment 1 (HADS, SIS, MoCA FMA, mRS)
Day 5–10 Discharge planning
Day 5–10 Discharge (First interview)
Within 24 hours after discharge: TUG, BB, ADL taxonomy, BI, HADS, EQ5D and FES.
Within two weeks after discharge: Second interview
Assessment 2 (1 month) ADL taxonomy, BI, BT, TUG, HADS, EQ5D, FES and mRS.
Next of kin: HADS
Assessment 3 (3 months) ADL taxonomy, BI, BB, TUG, HAD, EQ5D and FES, SIS, mRS and IPA-E.
Third interview with patients and interview with relatives.
Next of kin: HADS and CBS
Assessment 4 (12 months) BI, BB, TUG, HAD, EQ5D, FES, SIS, mRS and IPA-E. FMA and MoCA.
Next of kin: HADS and CBS