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The YOU CALL - WE CALL trial: impact of a multimodal support intervention after a "mild" stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95662526
Enrollment
384
Registered
2008-07-18
Start date
2008-12-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Mild stroke rehabilitation Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

Active experimental group: A multimodal (telephone, internet and paper) support intervention will be provided to participants randomly allocated to the experimental active "WE CALL" group. The teleph

Sponsors

Canadian Stroke Network (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults (greater than 18 years of age), male or female 2. Have sustained a first "mild" stroke defined as: 2.1. A score greater than 8.5 on the Canadian Neurological Scale, OR 2.2. A Modified Rankin Scale score 0 to 2, OR 2.3. Ability to accomplish basic activities of daily living

Exclusion criteria

Exclusion criteria: 1. Individuals who are unable to communicate in English or French 2. No telephone access

Design outcomes

Primary

MeasureTime frame
1. Unplanned-use of health services and planned-use will be identified as: 1.1. Number of doctor visits, emergency or medical clinic visits 1.2. Number of hospitalisations and any other use of other health care professionals (e.g. social worker, psychologist, physical therapist, occupational therapist, etc.) For the six-month period of the study and an additional six months follow up period, assessed at three months, six months, nine months and one-year. To minimise recall bias, these data will be collected by way of a frequency calendar where each participant will note the health services they used, reasons (e.g. a fall, dizziness, stroke, follow up appointment, physical therapy, etc.) and most importantly if the visit was planned (scheduled) or not (emergency). At the time of data coding, each entry will be scrutinised by three stroke specialist health professionals, not involved in the study, to differentiate noise (such as emergency for a cold or planned-visits for foot care) versus any stroke-related use of the health care system (e.g. emergency for a fall, dizziness, or follow up visit for hypertension or any other risk factors) upon which the program aims to have an effect. Each entry will be dichotomised as either planned for health promotion/prevention or unplanned for a negative event. 2. The 32 item questionnaire Quality of Life Index (QLI), which was developed from Ferran's conceptual model of quality of life and which has been used repeatedly with a stroke clientele was chosen as the primary outcome. Each item of the QLI as relating to four life domains (health and functioning, socio-economic, psychological/spiritual and family), is evaluated in terms of satisfaction and importance on a six-point scale. Scores for each domain and a global score are expressed from 0 to 30, a higher score indicating a better quality of life. This will be assessed at baseline, three months, six months and one-year follow up. 3. The EQ-5D composed of 5 items rated on a t

Secondary

MeasureTime frame
1. The LIFE-H will be used to measure the ICF participation domains. This questionnaire is composed of 77 items and covers 12 domains of participation. The first six domains: nutrition, fitness, personal care, communication, housing, and mobility refer to the accomplishment of daily activities whereas the last six: responsibilities, relationships, community life, education, employment and recreation refer to the accomplishment of social roles. Participants are asked about the degree of difficulty in accomplishing the activity or the social role (without difficulty, with difficulty, by substitution or not realised) as well as assistance used (technical assistance, physical arrangements or human help). From their answers to those two simple questions, scores for each domain and global score are derived and expressed from 0 to 9 where a higher score indicates a better participation. It takes between 20 - 30 minutes to administer. The "WE CALL" intervention, through support and information about available community resources, is expected to foster improvements in many different domains of community re-integration covered with the LIFE-H, especially in regards to social roles domains. 2. Depression will be measured using the Beck Depression Inventory II (BDI-II) created to correspond with the updated Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for depression. It is still composed of 21 items answered on a four-point Likert scale (score ranging 0 - 63) with a higher score indicating a greater severity of depression. A score of 0 - 13 is considered none or minimal range depression; 14 - 19 mild depression; 20 - 28 moderate depression; and 29 - 63 severe depression. Secondary outcomes measured at baseline, six months and one-year follow up.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026