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Promoting Community Reintegration for Young Adults With Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Narrative and Skills-building Intervention
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Stroke, Community reintegration, Narrative, Skill building

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Suzanne LoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Usual care group

Arm Description

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

Participants will receive usual stroke care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in the participants' level of depressive symptoms
The Chinese version of the 15-item Geriatric Depression Scale (GDS) will be used to measure participants' depressive symptoms. Studies support its utility in younger adults (>18 years old), with good diagnostic sensitivity and specificity. Each item represents symptoms of depression and describes a participant's condition in the preceding week; the participants answer each item with either 'yes' or 'no'. All items are summed (total score 0-15). A score of six or greater is a cutoff for depression. The GDS has a Cronbach's alpha of 0.78.
Change in the participants' level of health-related quality of life
Participants' health-related quality of life (HRQoL) will be measured by the Chinese version of the Stroke-Specific Quality of Life Scale (SSQOL-C), which has 47 items with 11 domains ranging from physical to psychosocial and participation. The items are about the health conditions of the participants and how much difficulty the participants have when doing everyday self-care tasks. The items are scored from 1 - 'strongly disagree/cannot do it' to 5 - 'strongly agree/no trouble'. Total score is yielded by summing all item scores (range 47-235): the higher the score, the higher the HRQoL. It has acceptable internal consistency (Cronbach's alpha: 0.63-0.93) and convergent validity.
Change in the participants' level of satisfaction with the performance of self-management behaviours
The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale (SSBPS-C) will be adopted to assess participants' satisfaction with the performance of self-management behaviours. Each item is scored using a range from 0 - 'very dissatisfied' to 10 - 'very satisfied'. Taking the sum of all item scores yields one total score (range 0-110), and the higher the score, the higher the satisfaction. This scale has a Cronbach's alpha of 0.93.
Change in the participants' level of self-efficacy
The Chinese version of the Stroke Self-Efficacy Questionnaire (SSEQ-C) will be used to measure self-efficacy. It has 13 items, each is scored using a scale from 0 - 'no confidence' to 10 - 'very confident'. The items are about the participants' perceived extent of confidence in doing everyday activities and self-management tasks. A total score is yielded by summing all items (range 0-130). A higher total score represents higher self-efficacy. The scale has acceptable internal consistency (Cronbach's alpha=0.92) and convergent validity.
Change in the participants' level of outcome expectation
The Chinese version of the Stroke Self-management Outcome Expectation Scale (SSOES-C) will be used to measure the participants' outcome expectation beliefs. It has 11 items, each rated using a scale from 0 - 'strongly disagree' to 10 - 'strongly agree'. The score of each item indicates the participants' confidence in the expected outcomes to occur. All item scores will be calculated by summation (total score 0-110). A higher score represents higher outcome expectations. This scale has good internal consistency (Cronbach's alpha=0.94).

Full Information

First Posted
September 17, 2020
Last Updated
June 5, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04560140
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Community reintegration, Narrative, Skill building

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Eligible participants will be randomly assigned to receive usual care with the novel 24-week Narrative and Skills-building Intervention.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Participants will receive usual stroke care.
Intervention Type
Behavioral
Intervention Name(s)
Narrative and Skills-building Intervention
Intervention Description
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 Measure Information:
Title
Change in the participants' level of community reintegration
Description
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.
Time Frame
Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Secondary Outcome Measure Information:
Title
Change in the participants' level of depressive symptoms
Description
The Chinese version of the 15-item Geriatric Depression Scale (GDS) will be used to measure participants' depressive symptoms. Studies support its utility in younger adults (>18 years old), with good diagnostic sensitivity and specificity. Each item represents symptoms of depression and describes a participant's condition in the preceding week; the participants answer each item with either 'yes' or 'no'. All items are summed (total score 0-15). A score of six or greater is a cutoff for depression. The GDS has a Cronbach's alpha of 0.78.
Time Frame
Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Title
Change in the participants' level of health-related quality of life
Description
Participants' health-related quality of life (HRQoL) will be measured by the Chinese version of the Stroke-Specific Quality of Life Scale (SSQOL-C), which has 47 items with 11 domains ranging from physical to psychosocial and participation. The items are about the health conditions of the participants and how much difficulty the participants have when doing everyday self-care tasks. The items are scored from 1 - 'strongly disagree/cannot do it' to 5 - 'strongly agree/no trouble'. Total score is yielded by summing all item scores (range 47-235): the higher the score, the higher the HRQoL. It has acceptable internal consistency (Cronbach's alpha: 0.63-0.93) and convergent validity.
Time Frame
Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Title
Change in the participants' level of satisfaction with the performance of self-management behaviours
Description
The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale (SSBPS-C) will be adopted to assess participants' satisfaction with the performance of self-management behaviours. Each item is scored using a range from 0 - 'very dissatisfied' to 10 - 'very satisfied'. Taking the sum of all item scores yields one total score (range 0-110), and the higher the score, the higher the satisfaction. This scale has a Cronbach's alpha of 0.93.
Time Frame
Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Title
Change in the participants' level of self-efficacy
Description
The Chinese version of the Stroke Self-Efficacy Questionnaire (SSEQ-C) will be used to measure self-efficacy. It has 13 items, each is scored using a scale from 0 - 'no confidence' to 10 - 'very confident'. The items are about the participants' perceived extent of confidence in doing everyday activities and self-management tasks. A total score is yielded by summing all items (range 0-130). A higher total score represents higher self-efficacy. The scale has acceptable internal consistency (Cronbach's alpha=0.92) and convergent validity.
Time Frame
Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Title
Change in the participants' level of outcome expectation
Description
The Chinese version of the Stroke Self-management Outcome Expectation Scale (SSOES-C) will be used to measure the participants' outcome expectation beliefs. It has 11 items, each rated using a scale from 0 - 'strongly disagree' to 10 - 'strongly agree'. The score of each item indicates the participants' confidence in the expected outcomes to occur. All item scores will be calculated by summation (total score 0-110). A higher score represents higher outcome expectations. This scale has good internal consistency (Cronbach's alpha=0.94).
Time Frame
Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Lo
Phone
852 39434485
Email
suzannelo@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suzanne Lo
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Phone
39434485
Email
suzannelo@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Phone
85239434485
Email
suzannelo@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33397316
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.
Results Reference
derived

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Promoting Community Reintegration for Young Adults With Stroke

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