GOThenburg Very Early Supported Discharged

NCT01622205 | Completed Phase 2

• 1 other identifier: GOTVED
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a generic term for cerebral infarction and cerebral haemorrhage and accounts for more patient days than any other single condition in Swedish health care. The Swedish guidelines for stroke treatment, issued by the national board for health and welfare, recommend early supported discharge for people with mild to moderate stroke. This is based on studies in which mean hospitalization was 18 days. The average length of stay in Sweden is 12 days. Policy makers would, however, like to shorten length of stay even further, and many patients are anxious to get home. Where and how to get support at home after discharge varies. This study is a randomized controlled trial in which half of the subjects are randomly allocated to very early supported discharge and the other half receives usual treatment. The investigators believe that patients discharged very early with support will experience less anxiety compared with controls. The investigators believe that early supported discharge is safe and that there is no difference between groups in bodily function. In order to test differences between the groups, the study requires approximately 110 subjects. Everyone who comes to the stroke unit at the hospital with a mild to moderate stroke can be recruited to the study. The intervention is having a team from the stroke unit visiting the patient's home and train him/her according to the individualized goals. The controls are discharged according to routine with support from primary care if needed. Assessments are made by therapists who are not involved in the training upon returning home, at 1 month, 3 to 12 months. The assessments include anxiety, motor activity, gait and balance, and ADL. Interviews will be done to highlight the subject's own experience. It is important to evaluate new methods and organizational changes prior to their implementation in health care. The investigators hope to show that very early supported discharge with rehabilitation is safe and provides confidence and less anxiety. Then it is possible to introduce a method that simultaneously improves patient outcome and increases availability of hospital beds.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Anxiety and depression (HADS)

  Anxiety is main outcome

  At 1 month, 3 months and 12 months, change from baseline

Secondary Outcomes (5)

• Barthel index

  At 1 month, 3 months and 12 months

• Balance

  At 1 month, 3 months and 12 months

• EQ5D

  At 1 month, 3 months and 12 months

• Impact of stroke

  At 1 month, 3 months and 12 months

• Re-hospitalisation

  At 1 month, 3 months and 12 months

Study Arms (2)

Active

EXPERIMENTAL

Early supported discharge

Other: Very early supported discharge (VESD)

Control

OTHER

Ordinary rehabilitation

Other: Ordinary rehabilitation

Interventions

Very early supported discharge (VESD) OTHER

A rehabilitation team made up of physiotherapists, occupational therapists and a stroke nurse from the stroke care unit continues the rehabilitation in the patient's home. The intervention has a person-centered approach which is based on who the person is: their context, their history, their next of kin, their individual strengths and weaknesses (28). Goal setting using questions as in the Canadian Occupational Performance Measure (29) takes part before the discharge. Examples of goals can be: to be able to go to the local store to buy milk, to be able to hang the laundry or to be able to travel on the tram to the daughter or how to manage the bills.

Also known as: VESD Very early supported discharge

Active

Ordinary rehabilitation OTHER

Ordinary rehabilitation

Also known as: C Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed stroke according to WHO´s criteria
• \> 18 years of age
• Living within 30 min from the stroke unit
• On day 2 NIHSS (National institute of health stroke scale) (22) of 0-16 points and Barthel 50-100 points.
• MoCA index \< 26 if Barthel = 100.

You may not qualify if:

• NIHSS \> 16
• Barthel \< 50
• Life expectancy \< 1 year (as with severe malignancy)
• Does not speak or communicate in Swedish prior to the incidence

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Stroke unit, Sahlgrenska University hospital

Gothenburg, Sweden

Location

Related Publications (6)

• Rafsten L, Palstam A, Sunnerhagen KS. Gothenburg very early supported discharge: evaluating differences in costs and environmental impact due to rehabilitation consumption during the first year in patients hospitalized due to mild stroke. BMC Health Serv Res. 2025 Mar 19;25(1):406. doi: 10.1186/s12913-025-12509-y.

  PMID: 40108578 DERIVED

• Nelsone L, Rafsten L, Abzhandadze T, Sunnerhagen KS. A cohort study on anxiety and perceived recovery 3 and 12 months after mild to moderate stroke. Front Neurol. 2023 Oct 10;14:1273864. doi: 10.3389/fneur.2023.1273864. eCollection 2023.

  PMID: 37900595 DERIVED

• Rafsten L, Danielsson A, Sunnerhagen KS. Self-perceived postural balance correlates with postural balance and anxiety during the first year after stroke: a part of the randomized controlled GOTVED study. BMC Neurol. 2020 Nov 9;20(1):410. doi: 10.1186/s12883-020-01982-z.

  PMID: 33167877 DERIVED

• Buvarp D, Rafsten L, Sunnerhagen KS. Predicting Longitudinal Progression in Functional Mobility After Stroke: A Prospective Cohort Study. Stroke. 2020 Jul;51(7):2179-2187. doi: 10.1161/STROKEAHA.120.029913. Epub 2020 Jun 17.

  PMID: 32568652 DERIVED

• Rafsten L, Danielsson A, Nordin A, Bjorkdahl A, Lundgren-Nilsson A, Larsson MEH, Sunnerhagen KS. Gothenburg Very Early Supported Discharge study (GOTVED): a randomised controlled trial investigating anxiety and overall disability in the first year after stroke. BMC Neurol. 2019 Nov 9;19(1):277. doi: 10.1186/s12883-019-1503-3.

  PMID: 31706292 DERIVED

• Sunnerhagen KS, Danielsson A, Rafsten L, Bjorkdahl A, Axelsson AB, Nordin A, Petersson CA, Lundgren-Nilsson A, Frojd K. Gothenburg very early supported discharge study (GOTVED) NCT01622205: a block randomized trial with superiority design of very early supported discharge for patients with stroke. BMC Neurol. 2013 Jun 24;13:66. doi: 10.1186/1471-2377-13-66.

  PMID: 23800106 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Katharina Stibrant Sunnerhagen, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed envelopes 20 per block
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Very early supported discharge vs ordinary discharge

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 19, 2012
• Study Start: May 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2019
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

SE (1)