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Completed

NCT Number: NCT07776392

Occupational Therapy Instructmental Activities of Daily Living and Psychosocial Modules Program for Stroke Survivors

The study aims to recruit and enroll 25 participants who meet specific criteria, which will be communicated to potential participants, along with information about the study's goals, time commitments, benefits, and risks. Participants can ask questions and receive consent forms to review and sign. Once participants sign consent forms, the primary investigator will generate non-identifiable codes for each participant using an Excel spreadsheet to maintain confidentiality and protect participant identities. Participants will be randomly assigned to one of two groups to minimize potential bias and ensure that each group is representative of the overall population. One group will receive a psychosocial intervention, while the other group will engage in instrumental activities of daily living.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Dallas, Texas, 75235-7200, United States

About this study

Stroke is a prevalent disability that affects 1 in 4 people in their lifetime, according to the World Stroke Organization. Stroke survivors often experience decreased active participation, long-term disabilities, and increased healthcare-related costs, highlighting the critical need for a local client-centered program that prioritizes the well-being and independence of stroke survivors. In a scoping review, Pyatak et al. found that community-based occupational therapy programs improve diverse older adults' quality of life, physical functioning, and mental health. These programs use personal goal setting, meaningful activities, and peer support to enhance overall well-being. They also address health disparities and emphasize client-centered approaches in culturally diverse communities. Lifestyle Redesign, a key component, teaches individuals how their daily choices impact long-term functioning, health, and well-being. This study aims to enhance the overall life satisfaction of stroke survivors by implementing an 8-week program that utilizes a comprehensive and personalized approach with client-based interventions. The program will incorporate various interventions such as meal preparation, exercise and leisure activities, health literacy, caregiver training, and mental well-being.

Research conducted by Guillaumier et al. has shown that online access is a promising approach to increasing effectiveness and improving outcomes. In light of this, weekly interventions for this study will be conducted online to address participants' questions, implement a home exercise program, and increase the accessibility of the program to stroke survivors who may have difficulty attending in-person appointments. This study proposal also aims to bridge the healthcare system and provide the support required for stroke survivors to navigate a healthy lifestyle. Additionally, the program seeks to enhance the life satisfaction of stroke survivors by addressing their physical, mental, and social health and well-being. By providing a holistic approach to stroke recovery, the program is designed to improve the quality of life for stroke survivors, alleviate the strain on healthcare resources, and provide the necessary support required for stroke survivors to maintain a healthy lifestyle.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be at least 18 years old;
  • Have a history of unilateral stroke no less than 3 months and be medically stable prior to the study
  • Be able to follow three-step commands
  • Have a score equal to or less than 20 on the 9-question Patient Health Questionnaire for without depression
  • Participants must commit to 8 weeks to participate in the full OT lifestyle redesign program
  • Be able to speak and understand English, as the program and study materials are in English
  • Internet access for zoom is required for participants

Exclusion criteria

listed.

  • Acute medical problems
  • Presence of any contraindications, injuries, or surgeries
  • Significant pain that interferes with participation in program activities
  • Use of medications that may affect participant's level of consciousness or fatigue
  • Impaired cognition level: Participants will need to have normal cognition in order to understand the study procedure. Therefore, we will use the Mini-Mental State Exam (MMSE) survey, with a total score of 30, to screen cognition. If the score on the MMSE survey is less than 24, the participant will be excluded.

Treatment and study plan

One group received the psychosocial intervention, while the other group engaged in IADL interventions.

Behavioral

The program took place in two separate office rooms at a Stroke Center at North Texas University. Participants engaged in an eight-week program targeting strategies for IADLs. Group sessions were held in person and lasted approximately 45 minutes. The sessions included an opening message, instructions, and structured group discussions. Research conducted by Guillaumier et al. (2022) has demonstrated that online access is a promising approach to increasing program effectiveness and improving outcomes. In light of this, this study will leverage a weekly, less than 30-minute phone consultation to address participants' questions, implement a home exercise program, and enhance accessibility for stroke survivors who may face challenges attending in-person appointments. Additionally, individual sessions were conducted via phone to cover the material discussed for that week and to facilitate knowledge retention, reflection, and teach-back opportunities by the research team members.

Primary outcomes

  1. Canadian Occupational Performance Measure

    Time frame: The pre- and post-surveys evaluate their change from the baseline prior to treatment, and the post-surveys are within one week of 8 weeks of intervention sessions.

    Participants repeated the Canadian Occupational Performance Measure (COPM) to assess satisfaction and performance and pre- and post-surveys to evaluate their knowledge of healthy habits and roles in terms of creating new roles, active participation, life habit enhancement, and preventative care.

    This outcome measure is a scale (1-10), where 1 = not important at all and 10 = very important in terms of satisfaction and performance.

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Official study title

Occupational Therapy Instrumental Activities of Daily Living and Psychosocial Program for Healthy Habits and Role of Stroke Survivors

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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