Tiny Hooves, Big Impact - A Feasibility Study of Miniature Equine-Assisted Diabetes Education for Children With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
The Diabetes & Equine Empowerment Program (DEEP) is a research study evaluating a novel diabetes education program that combines hands-on interactions with miniature horses and evidence-based diabetes self-management education for youth ages 8-20 years with diabetes. Participants and their caregivers attend four structured educational sessions led by a diabetes specialist and a certified equine specialist. Topics include diabetes self-management, coping skills, problem-solving, self-advocacy, and transition readiness. Researchers will evaluate whether the program is feasible to deliver, acceptable to participants and families, and helpful in supporting engagement in diabetes care. Participants will be followed for up to six months after the program, and study outcomes include satisfaction, diabetes-related distress, self-care behaviors, clinic attendance, and diabetes technology use.
In simple terms, this study is exploring whether learning about diabetes through guided activities with miniature horses can help children, adolescents, and young adults feel more confident in managing their diabetes, improve self-care skills, and become more engaged in their health care. The goal is to determine whether this innovative educational approach is practical to offer and valued by patients, families, and health care providers.
详细描述
Youth with diabetes often face challenges related to self-management, problem-solving, coping with the daily demands of diabetes, and developing the skills needed for increasing independence. Innovative approaches that promote engagement and active participation may help address these challenges while supporting diabetes education and self-confidence.
The Diabetes & Equine Empowerment Program (DEEP) was developed to integrate experiential learning with diabetes education through structured interactions with miniature horses. The program is designed to create a supportive, interactive environment in which participants can practice communication, goal setting, self-advocacy, and problem-solving while reinforcing key diabetes self-management concepts. Educational content is tailored to developmental level and incorporates activities intended to enhance engagement, self-efficacy, and readiness for independent diabetes management.
This single-arm feasibility study will evaluate the implementation of the DEEP program among youth with diabetes and their caregivers. Participants will complete a series of structured sessions facilitated by a diabetes specialist and a certified equine specialist. The study will examine the practicality of recruitment strategies, participant retention, attendance, and completion of study activities. Acceptability of the intervention will be assessed through participant and caregiver feedback regarding satisfaction, perceived value, and willingness to recommend the program to others.
In addition to feasibility and acceptability outcomes, exploratory measures will assess potential changes in diabetes-related psychosocial and behavioral outcomes, including diabetes distress, self-management behaviors, healthcare engagement, and diabetes technology utilization. Data collected through participant-reported measures and medical record review will be used to inform future research and the potential development of larger controlled studies evaluating equine-assisted diabetes education interventions. Participants will be followed for up to six months after program completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8 to 20 years
- •Diagnosis of type 1 or type 2 diabetes
- •Most recent HbA1c greater than 9.0% OR no diabetes clinic follow-up for more than 6 months
- •English-speaking participant and caregiver
- •Receiving diabetes care at the participating study site
- •Willing and able to participate in the DEEP intervention
- •Able to attend all four study sessions
- •Able to provide informed consent/assent, as applicable
- •Caregiver willing to participate in study activities and assessments
排除标准
- •Non-English-speaking participant or caregiver
- •Medical, physical, cognitive, or behavioral condition that would prevent safe participation in study activities
- •Significant fear of horses that would limit participation
- •Allergy to horses that would limit participation
- •Previous participation in the DEEP intervention
- •Inability or unwillingness to complete study procedures or follow-up assessments
- •Any condition that, in the opinion of the investigators, would make participation unsafe or interfere with study completion
研究组 & 干预措施
Diabetes & Equine Empowerment Program (DEEP)
Participants in this single-arm intervention will receive the Diabetes & Equine Empowerment Program (DEEP), a miniature equine-assisted diabetes education program. Participants and their caregivers will attend four structured sessions led by a diabetes specialist and a certified equine specialist. Sessions combine experiential learning activities with diabetes education focused on self-management, coping skills, problem-solving, self-advocacy, and transition readiness. The study will evaluate feasibility, acceptability, participant satisfaction, and exploratory psychosocial and behavioral outcomes.
干预措施: Diabetes & Equine Empowerment Program (DEEP) (Behavioral)
结局指标
主要结局
Participant Recruitment Rate
时间窗: From study initiation through completion of enrollment (approximately 9 months)
Recruitment feasibility will be assessed by the proportion of eligible participants who enroll in the four-session miniature equine-assisted diabetes education program, as documented in study enrollment records.
Participant Retention Rate
时间窗: From enrollment through completion of study participation (approximately 9 months)
Retention feasibility will be assessed by the proportion of enrolled participants who remain in the study and complete scheduled study assessments, as documented in study records.
Program Attendance Rate
时间窗: From enrollment through completion of study participation (approximately 9 months)
Attendance feasibility will be assessed by the proportion of scheduled miniature equine-assisted diabetes education sessions attended by participants, as documented in program attendance logs.
Program Completion Rate
时间窗: From enrollment through completion of study participation (approximately 9 months)
Completion feasibility will be assessed by the proportion of enrolled participants who complete all four miniature equine-assisted diabetes education sessions.
次要结局
- Change in Diabetes Distress Assessed by the Problem Areas in Diabetes Questionnaires (PAID-C/PAID-T)(Baseline to immediately after completion of the four-session DEEP program)
- Change in Diabetes Self-Management Behaviors Assessed by the Self-Care Inventory-Updated (SCI-U)(Baseline to immediately after completion of the four-session DEEP program)
- Routine Diabetes Appointment Attendance Assessed by Electronic Health Record Review(Six months before participation through six months after program completion)
- Diabetes Technology Initiation Assessed by Electronic Health Record Review(Program completion through six months after program completion)
研究者
Jennifer Pfieffer
Principal Investigator
Nemours Children's Health System