A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP). (DEEP)
Tiny Hooves, Big Impact - A Feasibility Study of Miniature Equine-Assisted Diabetes Education for Children With Diabetes
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jennifer E Pfieffer, APRN, PCNS-BC, ESMHL
- 電話番号：904-697-3600
- メール：Jennifer.Pfieffer@nemours.org
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
The Diabetes & Equine Empowerment Program (DEEP) is a behavioral and educational intervention that combines evidence-based diabetes self-management education with structured, hands-on interactions involving miniature horses.
Youth with diabetes and their caregivers participate in four facilitated sessions led by a diabetes specialist and a certified equine specialist.
Session activities are designed to reinforce diabetes self-management skills, coping strategies, problem-solving, communication, self-advocacy, and transition readiness through experiential learning.
The intervention aims to improve participant engagement, confidence in diabetes management, and readiness for increasing independence while providing a supportive and interactive learning environment.
The program is being evaluated for feasibility, acceptability, participant satisfaction, and potential effects on psychosocial and behavioral outcomes.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant Recruitment Rate
時間枠：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.
|
From study initiation through completion of enrollment (approximately 9 months)
|
|
Participant Retention Rate
時間枠：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.
|
From enrollment through completion of study participation (approximately 9 months)
|
|
Program Attendance Rate
時間枠：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.
|
From enrollment through completion of study participation (approximately 9 months)
|
|
Program Completion Rate
時間枠：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.
|
From enrollment through completion of study participation (approximately 9 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Diabetes Distress Assessed by the Problem Areas in Diabetes Questionnaires (PAID-C/PAID-T)
時間枠：Baseline to immediately after completion of the four-session DEEP program
|
Change in diabetes-related emotional distress among youth participants as measured by the Problem Areas in Diabetes questionnaires, including the PAID-C for participants ages 8-12 years and the PAID-T for participants ages 13-17 years.
Higher scores indicate greater diabetes-related distress
|
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)
時間枠：Baseline to immediately after completion of the four-session DEEP program
|
Change in diabetes self-management behaviors as measured by the Self-Care Inventory-Updated (SCI-U), a validated self-report questionnaire that assesses adherence to diabetes self-care activities, including blood glucose monitoring, medication administration, and diabetes-related self-management tasks.
Higher scores indicate better adherence to the diabetes care plan.
|
Baseline to immediately after completion of the four-session DEEP program
|
|
Routine Diabetes Appointment Attendance Assessed by Electronic Health Record Review
時間枠：Six months before participation through six months after program completion
|
Change in routine diabetes clinic appointment attendance as assessed through electronic health record review.
Attendance will be evaluated by comparing the proportion of scheduled diabetes clinic visits attended before participation and following completion of the DEEP program
|
Six months before participation through six months after program completion
|
|
Diabetes Technology Initiation Assessed by Electronic Health Record Review
時間枠：Program completion through six months after program completion
|
The number of participants who initiate diabetes technology, including continuous glucose monitoring and/or insulin pump therapy, within six months following program completion, as documented through electronic health record review.
|
Program completion through six months after program completion
|
協力者と研究者
捜査官
- スタディディレクター：Susana Patton, PhD, ABPP, CDCES、Nemours Children's Health
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- MOD00002923
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。