Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Carepartners adherence rate
研究概览
简要总结
Stroke affects both the carepartner (CP) and stroke survivor (SS), with CPs frequently feeling overwhelmed and exhausted. The investigators have developed a theory-based, family-centered intervention, Carepartner Collaborative Integrated Therapy (CARE-CITE) designed to positively engage CPs during SS daily activities and rehabilitation exercise practice in the home setting. Using a web-based program with exemplary interactive videos of family scenarios in the home, CARE-CITE guides the CP in collaborative goal setting and creating an autonomy-supportive environment with the SS to promote motivation and creative problem-solving.
This study will use the modified upper extremity-focused CARE-CITE intervention content to address gait rehabilitation, and test 4-weeks of CARE-CITE-Gait in 15 CP/SS dyads to determine if similar positive outcomes are seen with integration to gait rehabilitation. Over a period of one month, SS and CP will receive 2 two-hour home-based therapy visits with a licensed physical therapist to develop therapy goals related to gait, mobility and balance and develop a home exercise plan to improve function. The CP will receive two additional phone calls to discuss the online CARE-CITE educational modules. The overall impact of this work is the development of innovative family-centered telerehabilitation interventions to improve self-management and physical activity.
详细描述
Stroke affects both the carepartner (CP) and stroke survivor (SS), with CPs frequently feeling overwhelmed and exhausted. Rehabilitation therapy activities largely do not address CP's well-being. The investigators have developed a theory-based, family-centered intervention, Carepartner Collaborative Integrated Therapy (CARE-CITE) designed to positively engage CPs during SS daily activities and rehabilitation exercise practice in the home setting. Using a web-based program with exemplary interactive videos of family scenarios in the home, CARE-CITE guides the CP in collaborative goal setting and creating an autonomy-supportive environment with the SS to promote motivation and creative problem-solving. To date, CARE-CITE has been evaluated in SS with chronic stroke and coupled with upper extremity therapy interventions. Promising preliminary data showed improvement in CP psychosocial outcomes and SS upper extremity function. The potential impact of CARE-CITE on SS mobility and gait recovery is unknown.
The investigators now seek to broaden the scope of the intervention by pairing CARE-CITE with home-based gait and functional mobility training (CARE-CITE-Gait). The goal of this proposal is to assess the impact of a novel home-based CARE-CITE-Gait intervention using a user-friendly telehealth delivery system. Aim 1 will evaluate usability, acceptability, and feasibility of CARE-CITE-Gait. Aim 2 will use a single site, quasi-experimental design with repeated measures (two baseline visits, post, and 1-month follow-up) to test 4-weeks of CARE-CITE-Gait in 15 CP/SS dyads to determine if similar positive outcomes are seen. Wearable sensors will be used to evaluate physical activity within the home and community. These data will support a larger randomized controlled trial testing the CARE-CITE-Gait intervention.
Study participants will be identified and recruited with successful techniques established by the PI (Blanton) and Co-I (Kesar) within the Emory Healthcare system and regional Atlanta hospitals, partnering with clinical staff for referrals and meeting with local stroke support groups. All Emory Rehabilitation Hospital stroke admissions will be screened based upon study inclusion/exclusion criteria and contacted by the research coordinator, if eligible. Participant eligibility will be confirmed via telephone screen, and initial clinical evaluation will follow at the Emory Rehabilitation Clinic. Eligible dyads (CP and SS) will be consented and evaluated at Emory Rehabilitation Hospital. Administration of CARE-CITE Gait intervention will occur in participants' homes over a period of 4 weeks, which includes CP review of the online CARE-CITE Gait education modules, two 2-hour home visits and 2 telerehabilitation check in video conference calls. All dyads will receive compensation for study participation at the end of the 1-month follow-up or prorated based on completed study evaluations.
The overall impact of this work is the development of innovative family-centered telerehabilitation interventions to improve self-management and physical activity. By providing a family-focused approach to gait and physical activity interventions, this project will help develop more effective treatments that improve both carepartner and stroke survivor outcomes after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All SSs will be >3 months post-ischemic or hemorrhagic event, discharged from inpatient neurologic rehabilitation to their home, able to walk 10-meters with or without an assistive device, no severe cognitive deficits, no physician determined major medical or musculoskeletal problems that would limit participation, and a CP living in the home.
- •CPs must be >21 years old, able to read and write English and have no significant cognitive deficits. CPs will be defined as those individuals who are a spouse/partner or family member dwelling in the same household. CPs must be familiar with using a computer and accessing websites or be familiar with using a tablet (available for loan if no computer is available).
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Cognitively impaired or Individuals with Impaired Decision-Making Capacity
- •Individuals who are not able to clearly understand English
- •Community Participation
结局指标
主要结局
Carepartners adherence rate
时间窗: 1 month post intervention
Carepartners (CP) adherence will be measured by the number of modules reviewed (6 total modules). Higher number indicates better adherence.
Change in Post-Study System Usability Questionnaire (PSSUQ)
时间窗: Baseline, 1 month post intervention
The Post-Study System Usability Questionnaire will be administered to CPs at the post-treatment evaluation to gather additional data on CARE-CITE usability. The PSSUQ is a 19-item survey that measures users' perceived satisfaction with a product or system. Responses are given on a 7-point scale where 1 = strongly agree and 7 = strongly disagree. Responses are averaged to provide a total score between 1 and 7 where low answers indicate greater ease with using the CARE-CITE system.
Carepartner satisfaction
时间窗: 1 month post intervention
Carepartner satisfaction will be indicated by scores on a standardized system usability assessment and CARE-CITE module-specific questionnaires. At the end of each of the six modules, carepartners (CP) will be instructed to complete these questions immediately after reviewing a module. Satisfaction will be defined as (1) usefulness of overall content, (2) usefulness of written text, (3) usefulness of videos, (4) ease of use, and (5) acceptability. Each area will be rated using a 5-point Likert type response scale ranging from 1 = strongly disagree to 5 = strongly agree and average scores calculated for each subscale as well as a total score. Total score range 1-5. Higher score correlates with better outcome.
Retention rate
时间窗: 1 month post intervention
Retention of participants will be tracked, recording the percentage of dropouts. Lower percentage correlates with better outcome.
Recruitment rate
时间窗: 1 month post intervention
Recruitment rates will be calculated based on the percentage of those participants enrolled and randomized from those screened. Recruitment will be deemed feasible if the target enrollment of 15 dyads (2-3 dyads per month) is reached during the study timeframe.
Stroke survivors adherence rate
时间窗: 1 month post intervention
Adherence to the stroke survivors (SS) intervention will be measured by the number of weekly sessions attended (4 total sessions) and total number of hours attended (4 hours) of training completed. Higher number correlates with better outcome.
次要结局
- Change in Five Times Sit-To-Stand (5TSTS) score(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI)(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in Bakas Caregiving Outcomes Scale (BCOS) Score(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in stroke survivor endurance(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in carepartners Family Conflict using Family Caregiver Conflict Scale (FCCS) score(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in lower extremity Fugl-Meyer (FM) therapist standardized assessment score(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in stroke survivor gait speed(Baseline, 1 week post-intervention, 1 month follow up post-intervention)
- Change in SS Quality of Life using Stroke Impact Scale (SIS) score(Baseline, 1 week post-intervention, 1 month follow up post-intervention)