Pet Ownership and Glucose Control in Type 1 Diabetes
Impact of Pet Ownership on Glycemic Control in Youth With Type 1 Diabetes
調査の概要
詳細な説明
Type 1 diabetes mellitus (T1DM) affects 151,000 children and adolescents in the United States. Youth with T1DM are at a high risk for multiple psychosocial co-morbidities including poor health related quality of life (HRQoL) which is linked to medication non-compliance and increased risk for diabetes-related complications. Any reduction in the psychosocial adjustment difficulties related to T1DM could improve the medical outcome of children with T1DM.
Current standards for diabetes management reflect the need to maintain glucose control within a normal range. However, numerous reports indicate that normalization of blood glucose levels is seldom attainable in children and adolescents. Family cohesion, positive coping strategies, younger age of onset, social support and adequate self-regulatory behavior are found to favorably influence glycemic control. One may conclude that the presence of a companion animal, capable of enhancing the positive factors named above, would augment the array of tools available for the successful management of chronic illnesses such as T1DM.
There is a lack of studies assessing the impact of pet ownership on the health and well-being of adolescents. The process of caring for, loving and being loved by a companion animal could offer direct and/or indirect benefits to the HRQoL in children with T1DM. To the investigators' knowledge, there are no studies examining the impact of pet ownership on glycemic control and HRQoL in youth with T1DM.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Dallas、Texas、アメリカ、75390
- University of Texas Southwestern Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- English-speaking patients
- 10 to 18 years
- diagnosed with type 1 diabetes for at least 12 months
- poor diabetes control as defined by having a hemoglobin A1c value > 8%
Exclusion Criteria:
- type 2 diabetes
- developmental delay
- current participation in another study that may impact glycemic control
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:ランダム化
- 介入モデル:並列代入
- 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 |
|---|---|
|
偽コンパレータ:Picture of a fish
Participants will receive a picture of a betta fish.
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Participants will receive a picture of a betta fish.
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|
アクティブコンパレータ:Pet fish
Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
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Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
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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 |
|---|---|---|
|
Glycemic control
時間枠:12 months
|
Hemoglobin A1c values
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HRQoL
時間枠:9 months
|
Generic and diabetes-specific health related quality of life
|
9 months
|
|
Self Management of Diabetes in Adolescents
時間枠:12 months
|
Self management of diabetes in adolescence questionnaire
|
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Health care burden
時間枠:12 months
|
Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control
|
12 months
|
協力者と研究者
捜査官
- 主任研究者:Olga T Gupta, MD、Ut Southwestern
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。