StrokeNCT05185271
Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers
A study testing Dyad-focused strategy training in people with Stroke, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Dyad-focused strategy training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke survivors include that the survivor:
- ages 20 years and older;
- has been diagnosed with stroke;
- speaks Mandarin;
- is about to be discharged from inpatient wards to home or has been discharged home within the past 3 months;
- has an identified primary caregiver;
Show all 13Show fewer
- is able to provide informed consent.
- Caregivers include that the caregiver:
- ages 20 years and older;
- speaks Mandarin;
- 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);
- is available to participate in the intervention sessions with the survivor;
- is able to provide informed consent.
Who cannot join
- requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;
- has severe aphasia;
- is unable to participate in a 1-hour discussion session;
- has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from continually participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers: Intervention Development and a Feasibility Study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Stroke
- Being tested
- Dyad-focused strategy training
- Keywords
- Caregiver, Stroke, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyad-focused strategy trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyad- focused strategy training intervention | Experimental | The dyad-focused strategy training intervention protocol will be developed to help dyads manage the needs that they have as transitioning to the community.
The following theoretical frameworks and guidelines will be used to guide the development of the intervention: (1) the strategy training guideline outlined by Skidmore et al; (2) Bodenmann's framework of dyadic coping; and (3) Self-efficacy theory. Receives: Behavioral: Dyad-focused strategy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intervention, up to 2 months
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.
Measured: Immediately after intervention
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.
Measured: After intervention
Secondary outcomes (34)
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.
Measured: Change from baseline to immediately post-intervention
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".
Measured: Change from baseline to immediately post-intervention
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".
Measured: Change from post-intervention to 3-month follow-up
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".
Measured: Change from 3-month to 6-month follow-up
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."
Measured: Change from baseline to immediately post-intervention
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."
Measured: Change from post-intervention to 3-month follow-up
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."
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
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.
Measured: Change from baseline to immediately post-intervention
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.
Measured: Change from post-intervention to 3-month follow-up
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.
Measured: Change from 3-month to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start16 Nov 2021
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (76)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng-Hang Chang, Taipei Medical University
- Investigators
- Feng-Hang Chang, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185271
- Sponsor's protocol ID
- N202106087
- Status last verified
- Apr 2024
- First submitted
- 10 Dec 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juengst SB, Osborne CL, Holavanahalli R, Silva V, Kew CL, Nabasny A, Bell KR. Feasibility Study of Problem-Solving Training for Care Partners of Adults With Traumatic Brain Injury, Spinal Cord Injury, Burn Injury, or Stroke During the Inpatient Hospital Stay. Arch Rehabil Res Clin Transl. 2019 Jun 27;1(3-4):100009. doi: 10.1016/j.arrct.2019.100009. eCollection 2019 Dec.
PubMed 33543049Haley WE, Roth DL, Hovater M, Clay OJ. Long-term impact of stroke on family caregiver well-being: a population-based case-control study. Neurology. 2015 Mar 31;84(13):1323-9. doi: 10.1212/WNL.0000000000001418. Epub 2015 Mar 4.
PubMed 25740862Moon M. The Unprepared Caregiver. Gerontologist. 2017 Feb;57(1):26-31. doi: 10.1093/geront/gnw080. Epub 2016 Apr 21.
PubMed 27106827Hare R, Rogers H, Lester H, McManus R, Mant J. What do stroke patients and their carers want from community services? Fam Pract. 2006 Feb;23(1):131-6. doi: 10.1093/fampra/cmi098. Epub 2005 Nov 24.
PubMed 16308328Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
PubMed 16120836Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
PubMed 20813995Jolly M, Thakkar A, Mikolaitis RA, Block JA. Caregiving, dyadic quality of life and dyadic relationships in lupus. Lupus. 2015 Aug;24(9):918-26. doi: 10.1177/0961203314567749. Epub 2015 Feb 5.
PubMed 25661509Israelsson J, Persson C, Bremer A, Stromberg A, Arestedt K. Dyadic effects of type D personality and perceived control on health-related quality of life in cardiac arrest survivors and their spouses using the actor-partner interdependence model. Eur J Cardiovasc Nurs. 2020 Apr;19(4):351-358. doi: 10.1177/1474515119890466. Epub 2019 Nov 22.
PubMed 31752502Boehmer U, Stokes JE, Bazzi AR, Clark MA. Dyadic quality of life among heterosexual and sexual minority breast cancer survivors and their caregivers. Support Care Cancer. 2020 Jun;28(6):2769-2778. doi: 10.1007/s00520-019-05148-7. Epub 2019 Nov 14.
PubMed 31724075Barata NE. Dyadic Relationship and Quality of Life Patients with Chronic Kidney Disease. J Bras Nefrol. 2015 Jul-Sep;37(3):315-22. doi: 10.5935/0101-2800.20150051. English, Portuguese.
PubMed 26398641Lau BH, Wong DFK, Fung YL, Zhou J, Chan CLW, Chow AYM. Facing death alone or together? Investigating the interdependence of death anxiety, dysfunctional attitudes, and quality of life in patient-caregiver dyads confronting lung cancer. Psychooncology. 2018 Aug;27(8):2045-2051. doi: 10.1002/pon.4773. Epub 2018 Jun 14.
PubMed 29785836Al-Rawashdeh S, Alshraifeen A, Rababa M, Ashour A. Hope predicted quality of life in dyads of community-dwelling patients receiving hemodialysis and their family caregivers. Qual Life Res. 2020 Jan;29(1):81-89. doi: 10.1007/s11136-019-02378-4. Epub 2019 Dec 2.
PubMed 31792798Sterba KR, Zapka J, Cranos C, Laursen A, Day TA. Quality of Life in Head and Neck Cancer Patient-Caregiver Dyads: A Systematic Review. Cancer Nurs. 2016 May-Jun;39(3):238-50. doi: 10.1097/NCC.0000000000000281.
PubMed 26121180Santos M, Sousa C, Pereira M, Pereira MG. Quality of life in patients with multiple sclerosis: A study with patients and caregivers. Disabil Health J. 2019 Oct;12(4):628-634. doi: 10.1016/j.dhjo.2019.03.007. Epub 2019 Mar 28.
PubMed 31005483Zeren F, Gursoy E, Colak E. The Quality of Life and Dyadic Adjustment of Couples Receiving Infertility Treatment. Afr J Reprod Health. 2019 Mar;23(1):117-127. doi: 10.29063/ajrh2019/v23i1.12.
PubMed 31034178
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers: Intervention Development and a Feasibility Study
- ClinicalTrials.gov ID
- NCT05185271
- Acronym / sponsor ID
- N202106087
- Conditions
- Stroke
- Keywords
- Caregiver, Stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyad- focused strategy training intervention | Experimental | Behavioral: Dyad-focused strategy trainingThe dyad-focused strategy training intervention protocol will be developed to help dyads manage the needs that they have as transitioning to the community. The following theoretical frameworks and guidelines will be used to guide the development of the intervention: (1) the strategy training guideline outlined by Skidmore et al; (2) Bodenmann's framework of dyadic coping; and (3) Self-efficacy theory. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ages 20 years and older;
- has been diagnosed with stroke;
- speaks Mandarin;
- is about to be discharged from inpatient wards to home or has been discharged home within the past 3 months;
- has an identified primary caregiver;
Key exclusion criteria (4 listed)
- requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;
- has severe aphasia;
- is unable to participate in a 1-hour discussion session;
- has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from continually participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyad-focused strategy trainingRehabilitation 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. | Behavioural | Dyad- focused strategy training intervention |
Primary outcome
Pittsburgh Rehabilitation Participation Scale (PRPS)
Time frame: During intervention, up to 2 months
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.
Client Satisfaction Questionnaire (CSQ)
Time frame: Immediately after intervention
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.
Qualitative data
Time frame: After intervention
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.
34 secondary outcomes
Goal Attainment Scaling (GAS)
Time frame: Change from baseline to immediately post-intervention
World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version
Time frame: Change from baseline to immediately post-intervention
World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version
Time frame: Change from post-intervention to 3-month follow-up
World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version
Time frame: Change from 3-month to 6-month follow-up
General Self-Efficacy Scale (GSES)
Time frame: Change from baseline to immediately post-intervention
General Self-Efficacy Scale (GSES)
Time frame: Change from post-intervention to 3-month follow-up
General Self-Efficacy Scale (GSES)
Time frame: Change from 3-month to 6-month follow-up
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Time frame: Change from baseline to immediately post-intervention
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Time frame: Change from post-intervention to 3-month follow-up
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Time frame: Change from 3-month to 6-month follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline to immediately post-intervention
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from post-intervention to 3-month follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from 3-month to 6-month follow-up
Dyadic Relationship Scale (DRS)
Time frame: Change from baseline to immediately post-intervention
Dyadic Relationship Scale (DRS)
Time frame: Change from post-intervention to 3-month follow-up
Dyadic Relationship Scale (DRS)
Time frame: Change from 3-month to 6-month follow-up
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
Time frame: Change from baseline to immediately post-intervention
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
Time frame: Change from post-intervention to 3-month follow-up
Activity Measure for Post-Acute Care Short Forms
Time frame: Change from 3-month to 6-month follow-up
Trail-Making Test (TMT A and B)
Time frame: Change from baseline to immediately post-intervention
Trail-Making Test (TMT A and B)
Time frame: Change from post-intervention to 3-month follow-up
Trail-Making Test (TMT A and B)
Time frame: Change from 3-month to 6-month follow-up
Stroop Test
Time frame: Change from baseline to immediately post-intervention
Stroop Test
Time frame: Change from post-intervention to 3-month follow-up
Stroop Test
Time frame: Change from 3-month to 6-month follow-up
Montreal Cognitive Assessment (MoCA)
Time frame: Change from baseline to immediately post-intervention
Montreal Cognitive Assessment (MoCA)
Time frame: Change from post-intervention to 3-month follow-up
Montreal Cognitive Assessment (MoCA)
Time frame: Change from 3-month to 6-month follow-up
Preparedness for Caregiving Scale (CPS)
Time frame: Change from baseline to immediately post-intervention
Preparedness for Caregiving Scale (CPS)
Time frame: Change from post-intervention to 3-month follow-up
Preparedness for Caregiving Scale (CPS)
Time frame: Change from 3-month to 6-month follow-up
The Zarit Burden Interview (ZBI)
Time frame: Change from baseline to immediately post-intervention
The Zarit Burden Interview (ZBI)
Time frame: Change from post-intervention to 3-month follow-up
The Zarit Burden Interview (ZBI)
Time frame: Change from 3-month to 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 33543049Juengst SB, Osborne CL, Holavanahalli R, Silva V, Kew CL, Nabasny A, Bell KR. Feasibility Study of Problem-Solving Training for Care Partners of Adults With Traumatic Brain Injury, Spinal Cord Injury, Burn Injury, or Stroke During the Inpatient Hospital Stay. Arch Rehabil Res Clin Transl. 2019 Jun 27;1(3-4):100009. doi: 10.1016/j.arrct.2019.100009. eCollection 2019 Dec.
- Background: PubMed 25740862Haley WE, Roth DL, Hovater M, Clay OJ. Long-term impact of stroke on family caregiver well-being: a population-based case-control study. Neurology. 2015 Mar 31;84(13):1323-9. doi: 10.1212/WNL.0000000000001418. Epub 2015 Mar 4.
- Background: PubMed 27106827Moon M. The Unprepared Caregiver. Gerontologist. 2017 Feb;57(1):26-31. doi: 10.1093/geront/gnw080. Epub 2016 Apr 21.
- Background: PubMed 16308328Hare R, Rogers H, Lester H, McManus R, Mant J. What do stroke patients and their carers want from community services? Fam Pract. 2006 Feb;23(1):131-6. doi: 10.1093/fampra/cmi098. Epub 2005 Nov 24.
- Background: PubMed 16120836Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
- Background: PubMed 20813995Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
- Background: PubMed 25661509Jolly M, Thakkar A, Mikolaitis RA, Block JA. Caregiving, dyadic quality of life and dyadic relationships in lupus. Lupus. 2015 Aug;24(9):918-26. doi: 10.1177/0961203314567749. Epub 2015 Feb 5.
- Background: PubMed 31752502Israelsson J, Persson C, Bremer A, Stromberg A, Arestedt K. Dyadic effects of type D personality and perceived control on health-related quality of life in cardiac arrest survivors and their spouses using the actor-partner interdependence model. Eur J Cardiovasc Nurs. 2020 Apr;19(4):351-358. doi: 10.1177/1474515119890466. Epub 2019 Nov 22.
- Background: PubMed 31724075Boehmer U, Stokes JE, Bazzi AR, Clark MA. Dyadic quality of life among heterosexual and sexual minority breast cancer survivors and their caregivers. Support Care Cancer. 2020 Jun;28(6):2769-2778. doi: 10.1007/s00520-019-05148-7. Epub 2019 Nov 14.
- Background: PubMed 26398641Barata NE. Dyadic Relationship and Quality of Life Patients with Chronic Kidney Disease. J Bras Nefrol. 2015 Jul-Sep;37(3):315-22. doi: 10.5935/0101-2800.20150051. English, Portuguese.
- Background: PubMed 29785836Lau BH, Wong DFK, Fung YL, Zhou J, Chan CLW, Chow AYM. Facing death alone or together? Investigating the interdependence of death anxiety, dysfunctional attitudes, and quality of life in patient-caregiver dyads confronting lung cancer. Psychooncology. 2018 Aug;27(8):2045-2051. doi: 10.1002/pon.4773. Epub 2018 Jun 14.
- Background: PubMed 31792798Al-Rawashdeh S, Alshraifeen A, Rababa M, Ashour A. Hope predicted quality of life in dyads of community-dwelling patients receiving hemodialysis and their family caregivers. Qual Life Res. 2020 Jan;29(1):81-89. doi: 10.1007/s11136-019-02378-4. Epub 2019 Dec 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Hang Chang principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyad-focused strategy training in people with Stroke, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Rehabilitation Participation Scale (PRPS) (time frame: During intervention, up to 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185271, which also lists 76 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.