Clinical trial NCT04560140: Promoting Community Reintegration for Young Adults With Stroke
Official title: Promoting Community Reintegration Using Narratives and Skills Building for Young Adults With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Community reintegration
Narrative
Skill building
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

Detailed description: This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. Participants will be facilitated to narrate their survival experiences and rebuild core life skills. Outcomes including community reintegration, depressive symptoms, health-related quality of life, self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours will be measured. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

Eligibility criteria: Inclusion Criteria:

* (1) are 18-64 years of age,
* (2) have a clinical diagnosis of first-ever or recurrent ischaemic or haemorrhagic stroke,
* (3) are living at home after discharge from hospital,
* (4) have a Montreal Cognitive Assessment score \>20,
* (5) have a modified Rankin Scale score ≥3,
* (6) can communicate in Cantonese, and
* (7) are able to attend all intervention sessions.

Exclusion Criteria:

* 1) transient ischaemic attack, subdural or epidural haemorrhage,
* 2) experienced cerebrovascular events due to tumours or head trauma,
* 3) mental condition such as depression, schizophrenia, bipolar or personality disorder,
* 4) incomprehensible speech or difficulty in comprehending conversations, or
* 5) have received a self-management programme in the past.

Primary outcomes:
measure: Change in the participants' level of community reintegration
timeFrame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Secondary outcomes:
measure: Change in the participants' level of depressive symptoms
timeFrame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
measure: Change in the participants' level of health-related quality of life
timeFrame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
measure: Change in the participants' level of satisfaction with the performance of self-management behaviours
timeFrame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
measure: Change in the participants' level of self-efficacy
timeFrame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
measure: Change in the participants' level of outcome expectation
timeFrame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Suzanne Lo
Study officials:
affiliation: Chinese University of Hong Kong
name: Suzanne Lo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo SHS, Chau JPC, Choi KC, Shum EWC, Yeung JHM, Li SH. Promoting community reintegration using narratives and skills building for young adults with stroke: a protocol for a randomised controlled trial. BMC Neurol. 2021 Jan 4;21(1):3. doi: 10.1186/s12883-020-02015-5.