Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers

Stroke Clinical Trial

Official title:

Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers: Intervention Development and a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05185271
• Other study ID #: N202106087
• Status: Completed
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases. In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads. A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited. The participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes at baseline, post-intervention, and 3-month and 6-month follow-ups. Quantitative data will be analyzed descriptively.

Description:

Stroke is the leading cause of death and adult disability. Transitioning from hospital to home is a challenging process for stroke survivors and their families, leading to frustration and adverse health outcomes for survivors and caregivers. To address both the survivor and caregiver needs, dyad-focused interventions are necessary to be implemented in the transitioning process. However, very few interventions were designed to address the needs of the dyad and place an equal emphasis on both survivors' and caregivers' outcomes. The purpose of this study is to develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases. In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads. A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited. Adult stroke survivors who have been diagnosed with stroke, are about to be discharged from inpatient wards to home or has been discharged home within the past 3 months, have an identified adult caregiver who provides care or assistance of any kind and taking responsibility for the survivor and is available to participate in the intervention sessions with the survivor will be eligible to participate in the study. These participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes such as goal attainment, quality of life, self-efficacy, participation, depressive symptoms, and survivor-caregiver relationship at baseline, post-intervention, and 3-month and 6-month follow-ups. The feasibility indicators, such as recruitment rates and intervention attendance and adherence, will be evaluated by questionnaires, field notes, and qualitative interviews after the interventions are completed. Quantitative data will be analyzed descriptively; while data obtained from the outcome measures will be examined using Wilcoxon signed rank test and effect size (r) to compare the differences between the pre- and post-intervention scores. Qualitative data will be analyzed using thematic analysis method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

Stroke survivors include that the survivor:

1. ages 20 years and older;

2. has been diagnosed with stroke;

3. speaks Mandarin;

4. is about to be discharged from inpatient wards to home or has been discharged home within the past 3 months;

5. has an identified primary caregiver;

6. is able to provide informed consent.

Caregivers include that the caregiver:

1. ages 20 years and older;

2. speaks Mandarin;

3. is the primary caregiver recognized by the survivor (living with the survivor or providing daily care to the survivor for at least 10 hours per week);

4. is available to participate in the intervention sessions with the survivor;

5. is able to provide informed consent.

Exclusion Criteria:

1. requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;

2. has severe aphasia;

3. is unable to participate in a 1-hour discussion session;

4. has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from continually participating in the study.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Dyad-focused strategy training
Rehabilitation therapists will be hired to deliver the intervention to the stroke survivors-caregiver dyads on a one-to-two base. The therapist will ask the dyad to identify their shared goals and provide them the global strategy "Goal-Plan-Do-Check" (also called guided discovery strategy), which involves (1) setting a goal to address the barriers, (2) developing a plan to address the goal, (3) doing the plan, and (4) checking if the plan worked or required revising. This procedure will be repeated iteratively until the dyad's goal is met, and the next goal can be moved on to.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

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* Note: There are 76 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	National Institutes of Health Stroke Scale	The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The score will be calculated to quantify stroke severity.	At baseline
Other	Modified Rankin Scale (MRS)	The MRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 ( Health without symptoms to death).	Change from baseline to immediately post-intervention
Other	Modified Rankin Scale (MRS)	The MRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 ( Health without symptoms to death).	Change from post-intervention to 3-month follow-up
Other	Modified Rankin Scale (MRS)	The MRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 ( Health without symptoms to death).	Change from 3-month to 6-month follow-up
Other	HEAL Positive Outlook questionnaire (Short form)	HEAL positive outlook questionnaire is a self-report measure that assesses participants' positive attitudes. The short form contains six items. Responses to questions are on a 1-5 Likert scale where 1 represents "Not at all" and 4 represents "Extremely ."	Change from baseline to immediately post-intervention
Other	HEAL Positive Outlook questionnaire (Short form)	HEAL positive outlook questionnaire is a self-report measure that assesses participants' positive attitudes. The short form contains six items. Responses to questions are on a 1-5 Likert scale where 1 represents "Not at all" and 4 represents "Extremely ."	Change from post-intervention to 3-month follow-up
Other	HEAL Positive Outlook questionnaire (Short form)	HEAL positive outlook questionnaire is a self-report measure that assesses participants' positive attitudes. The short form contains six items. Responses to questions are on a 1-5 Likert scale where 1 represents "Not at all" and 4 represents "Extremely ."	Change from 3-month to 6-month follow-up
Other	HEAL Patient-Provider Connection	HEAL Patient-Provider Connection is a self-report measure that assesses the relationship between a patient and a health care provider. It contains seven items. Responses to questions are on a 1-5 Likert scale where 1 represents "Not at all" and 4 represents "Extremely ."	After the fifth intervention session, an average of 3 weeks
Other	HEAL Treatment Expectancy	HEAL Treatment Expectancy is a self-report measure that assesses patients' expectations from the intervention. It contains six items. Responses to questions are on a 1-5 Likert scale where 1 represents "Not at all" and 4 represents "Extremely ."	After the first intervention session, an average of 1 week
Primary	Pittsburgh Rehabilitation Participation Scale (PRPS)	The PRPS, a clinician-rated instrument, measures patients' participation on a 6-point Likert-type scale. A higher point reflects better participation in each intervention session.	During intervention, up to 2 months
Primary	Client Satisfaction Questionnaire (CSQ)	The CSQ is an 8-item measure of client satisfaction with the intervention. It allows clients to rate on a 4-point scale where 1 represents "Not at all" and 4 represents "Extremely ." A higher score reflects higher satisfaction and acceptability of the intervention.	Immediately after intervention
Primary	Qualitative data	Qualitative data will be collected through field notes taken by therapists after each intervention session and in-person qualitative interviews with participants and their therapists using semi-structured questionnaires.	After intervention
Secondary	Goal Attainment Scaling (GAS)	GAS is a method of scoring the extent to which patients' individual goals are achieved in intervention. If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome, this is scored at +1 (somewhat better) or +2 (much better). If they achieve a worse than expected outcome this is scored at -1 (partially achieved), -2 (No change) or -3 (much worse). Goals will be weighted to take account of the relative importance of the goal to the individual and/or the anticipated difficulty of achieving it.	Change from baseline to immediately post-intervention
Secondary	World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version	The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".	Change from baseline to immediately post-intervention
Secondary	World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version	The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".	Change from post-intervention to 3-month follow-up
Secondary	World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version	The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".	Change from 3-month to 6-month follow-up
Secondary	General Self-Efficacy Scale (GSES)	The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."	Change from baseline to immediately post-intervention
Secondary	General Self-Efficacy Scale (GSES)	The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."	Change from post-intervention to 3-month follow-up
Secondary	General Self-Efficacy Scale (GSES)	The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."	Change from 3-month to 6-month follow-up
Secondary	Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)	The PM-3D4D is a 19-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community. Respondents are asked to rate each item on four dimensions: (1) 'Diversity of participation' (yes [1] vs. no [0]); (2) 'Frequency'(5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes [1] vs. no[0]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" [1] to "not difficult at all" [4]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.	Change from baseline to immediately post-intervention
Secondary	Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)	The PM-3D4D is a 19-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community. Respondents are asked to rate each item on four dimensions: (1) 'Diversity of participation' (yes [1] vs. no [0]); (2) 'Frequency'(5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes [1] vs. no[0]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" [1] to "not difficult at all" [4]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.	Change from post-intervention to 3-month follow-up
Secondary	Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)	The PM-3D4D is a 19-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community. Respondents are asked to rate each item on four dimensions: (1) 'Diversity of participation' (yes [1] vs. no [0]); (2) 'Frequency'(5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes [1] vs. no[0]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" [1] to "not difficult at all" [4]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.	Change from 3-month to 6-month follow-up
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS is a fourteen-item scale that generates seven items related to anxiety and seven related to depression. Each item on the questionnaire is scored from 0-3, which means that a person can score between 0 and 21 for either anxiety or depression. Higher scores mean a worse outcome.	Change from baseline to immediately post-intervention
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS is a fourteen-item scale that generates seven items related to anxiety and seven related to depression. Each item on the questionnaire is scored from 0-3, which means that a person can score between 0 and 21 for either anxiety or depression. Higher scores mean a worse outcome.	Change from post-intervention to 3-month follow-up
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS is a fourteen-item scale that generates seven items related to anxiety and seven related to depression. Each item on the questionnaire is scored from 0-3, which means that a person can score between 0 and 21 for either anxiety or depression. Higher scores mean a worse outcome.	Change from 3-month to 6-month follow-up
Secondary	Dyadic Relationship Scale (DRS)	The DRS measures negative and positive dyadic interactions from the perspective of both patients and the family caregivers. The patient version (10 items) and the caregiver version (11 items) have two subscales: dyadic strain and positive dyadic interaction. Each item included a four-option response (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Higher scores on each of these scales indicate higher strain levels and positive interaction, respectively.	Change from baseline to immediately post-intervention
Secondary	Dyadic Relationship Scale (DRS)	The DRS measures negative and positive dyadic interactions from the perspective of both patients and the family caregivers. The patient version (10 items) and the caregiver version (11 items) have two subscales: dyadic strain and positive dyadic interaction. Each item included a four-option response (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Higher scores on each of these scales indicate higher strain levels and positive interaction, respectively.	Change from post-intervention to 3-month follow-up
Secondary	Dyadic Relationship Scale (DRS)	The DRS measures negative and positive dyadic interactions from the perspective of both patients and the family caregivers. The patient version (10 items) and the caregiver version (11 items) have two subscales: dyadic strain and positive dyadic interaction. Each item included a four-option response (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Higher scores on each of these scales indicate higher strain levels and positive interaction, respectively.	Change from 3-month to 6-month follow-up
Secondary	Activity Measure for Post-Acute Care (AM-PAC) Short Forms	The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.	Change from baseline to immediately post-intervention
Secondary	Activity Measure for Post-Acute Care (AM-PAC) Short Forms	The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.	Change from post-intervention to 3-month follow-up
Secondary	Activity Measure for Post-Acute Care Short Forms	The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.	Change from 3-month to 6-month follow-up
Secondary	Trail-Making Test (TMT A and B)	The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate a poorer outcome.	Change from baseline to immediately post-intervention
Secondary	Trail-Making Test (TMT A and B)	The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate a poorer outcome.	Change from post-intervention to 3-month follow-up
Secondary	Trail-Making Test (TMT A and B)	The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate a poorer outcome.	Change from 3-month to 6-month follow-up
Secondary	Stroop Test	The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.	Change from baseline to immediately post-intervention
Secondary	Stroop Test	The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.	Change from post-intervention to 3-month follow-up
Secondary	Stroop Test	The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.	Change from 3-month to 6-month follow-up
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health.; The score ranges from 0 to 30. A score of 26 and higher is considered normal.	Change from baseline to immediately post-intervention
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health.; The score ranges from 0 to 30. A score of 26 and higher is considered normal.	Change from post-intervention to 3-month follow-up
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health.; The score ranges from 0 to 30. A score of 26 and higher is considered normal.	Change from 3-month to 6-month follow-up
Secondary	Preparedness for Caregiving Scale (CPS)	The CPS is a caregiver self-rated instrument that consists of eight items that ask caregivers how well prepared they believe they are for multiple domains of caregiving. Responses rate on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score, the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.	Change from baseline to immediately post-intervention
Secondary	Preparedness for Caregiving Scale (CPS)	The CPS is a caregiver self-rated instrument that consists of eight items that ask caregivers how well prepared they believe they are for multiple domains of caregiving. Responses rate on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score, the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.	Change from post-intervention to 3-month follow-up
Secondary	Preparedness for Caregiving Scale (CPS)	The CPS is a caregiver self-rated instrument that consists of eight items that ask caregivers how well prepared they believe they are for multiple domains of caregiving. Responses rate on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score, the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.	Change from 3-month to 6-month follow-up
Secondary	The Zarit Burden Interview (ZBI)	The ZBI, a caregiver self-report measure, contains 22 items to assess the caring burden. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). A higher score means a worse outcome.	Change from baseline to immediately post-intervention
Secondary	The Zarit Burden Interview (ZBI)	The ZBI, a caregiver self-report measure, contains 22 items to assess the caring burden. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). A higher score means a worse outcome.	Change from post-intervention to 3-month follow-up
Secondary	The Zarit Burden Interview (ZBI)	The ZBI, a caregiver self-report measure, contains 22 items to assess the caring burden. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). A higher score means a worse outcome.	Change from 3-month to 6-month follow-up