Promoting Community Reintegration for Young Adults With Stroke

NCT04560140 | Recruiting

• 1 other identifier: NSI
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Community reintegration; Narrative; Skill building

Outcome Measures

Primary Outcomes (1)

• Change in the participants' level of community reintegration

  The Chinese version of the Reintegration to Normal Living Index (RNIL-C) will be used to assess the participants' level of community reintegration. It consists of 11 items in eight domains: mobility, self-care, daily work and school activity, recreational and social activities, family roles, personal relationships, presentation of self to others and general coping skills. Participants are asked to rate the extent to which each item describes their situation on a scale from 1 - 'a small extent' to 5 - 'a great extent'. The total score is calculated by summation and normalised to give 100 with a total score range of 25 to 100. A higher score indicates better community reintegration. The RNIL-C has high internal consistency (Cronbach's alpha=0.92) and good convergent validity.

  Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

Secondary Outcomes (5)

• Change in the participants' level of depressive symptoms

  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

  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

  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

  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

  Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Eligible participants will be randomly assigned to receive usual care with the novel 24-week Narrative and Skills-building Intervention.

Behavioral: Narrative and Skills-building Intervention

Usual care group

NO INTERVENTION

Participants will receive usual stroke care.

Interventions

Narrative and Skills-building Intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Suzanne Lo

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Stroke; Narration

Condition Hierarchy (Ancestors)

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

Study Officials

• Suzanne Lo

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Lo

CONTACT

852 39434485; suzannelo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)