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Recruiting NCT04560140

Promoting Community Reintegration for Young Adults With Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Narrative and Skills-building Intervention.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Promoting Community Reintegration Using Narratives and Skills Building for Young Adults With Stroke

Overview

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.

Interventions

  • Behavioral Narrative and Skills-building Intervention
    The intervention is grounded in Narrative Theory and Bandura's principles of Self-efficacy and Outcome Expectation. It will consist of eight individual sessions over six months delivered by a facilitator. Participants will be facilitated to narrate their survival experiences and rebuild core life skills.

Primary outcome measures

  • Change in the participants' level of community reintegration [Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
Secondary outcome measures (5)
  • Change in the participants' level of depressive symptoms [Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of health-related quality of life [Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of satisfaction with the performance of self-management behaviours [Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of self-efficacy [Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of outcome expectation [Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Hong Kong · 1 center
  • Suzanne Lo — Hong Kong

Publications

  • 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. PMID 33397316

Identifiers

NCT: NCT04560140 · NSI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗