Care4Stroke+ program: Caregiver mediated exercises with e-health support for early supported discharge after acquired brain injury.

Care4Stroke+ program: Caregiver mediated exercises with e-health support for early supported discharge after acquired brain injury. - Care4Stroke+

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41664

Enrollment

176

Registered

2012-11-01

Start date

2013-02-15

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acquired brain injury stroke

Interventions

Participants will be allocated to either 8 weeks of the CARE4STROKE+ programme in addition to usual care or to 8 weeks of usual care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient: 1) 18 years or older 2) written informed consent 3) able to understand the Dutch language (on sufficient level to understand instructions and complete the questionnaires) 4) knowing and able to appoint a caregiver who he/she wants to participate in the programme (with a maximum of two caregivers) 5) living independently before the acquired brain injury 6) planned to be discharged home 7) being able to follow instructions (a MMSE score > 18 points) 8) Functional Ambulation Score (FAC)

Exclusion criteria

Exclusion criteria: For patient and caregiver: Serious comorbidity which interferes with participation

Design outcomes

Primary

Measure	Time frame
Primary measurements of outcome: 1) Length of Stay; 2) self-reported health-status with the Stroke Impact Scale (SIS version 3.0) and 3) Self-Efficacy for patient (Sef-Efficacy for Symptom Management Scal (SESx)) and caregiver (Revised Scale for Caregiving Self-Efficacy (RSCSE)).	—

Secondary

Measure	Time frame
Secondary outcomes for included stroke patients are EuroQol-5D (EQ-5D), the Barthel Index, Rivermead Mobility Index, Berg Balance Scale, 5 meter walking speed, 6 minute walking test, Timed Up and Go Test, the Motricity Index (leg), The Fugl-Meyer assessment (leg), Nottingham Extended Activities of Daily Living and modified Rankin Scale. In order to track the daily activity, patients will wear a wireless activity monitor on the wrist one week before and after the intervention. In addition, patients keep a diary to record adherence to the exercise program and emerging complications. Caregiver burden will be evaluated with the Caregiver Strain Index and Carer Quality of Life Index. For patients and caregivers the Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Family Assessment Device and Personal Opinion Questionnaire for empowerment will be used. In addition each couple will use a cost diary.	—

Measure

Time frame

Secondary outcomes for included stroke patients are EuroQol-5D (EQ-5D), the Barthel Index, Rivermead Mobility Index, Berg Balance Scale, 5 meter walking speed, 6 minute walking test, Timed Up and Go Test, the Motricity Index (leg), The Fugl-Meyer assessment (leg), Nottingham Extended Activities of Daily Living and modified Rankin Scale. In order to track the daily activity, patients will wear a wireless activity monitor on the wrist one week before and after the intervention. In addition, patients keep a diary to record adherence to the exercise program and emerging complications. Caregiver burden will be evaluated with the Caregiver Strain Index and Carer Quality of Life Index. For patients and caregivers the Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Family Assessment Device and Personal Opinion Questionnaire for empowerment will be used. In addition each couple will use a cost diary.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)