Medication Management Among Individuals With Neurodevelopmental Disabilities (M-MIND)
調査の概要
詳細な説明
In this study, an application will be iteratively developed and tested using RL-adaptive support for young adults with disabilities, with the goal to promote the transition to independent self-medication administration among young adults with cerebral palsy and spina bifida.
Stochastic mathematical models of how individuals with varying levels of executive function and psychomotor skills will respond to the interventions (i.e. the different types and formats of messages) of the RL-adaptive support will be developed.
Up to 6 dyads of individuals with disabilities and their caregivers were intended to be recruited to collaborate in defining the features and content of the RL-adaptive support. The investigators recruited 3 dyads.
The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each:
- young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team,
- young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and
- young adult uses the electronic medication pillbox + the RL-adaptive support including push notifications in the form of text messages + caregiver uses the pillbox opening notification app
The goal was to reduce the number of caregiver prompts necessary for the medication pillbox to be opened. Using these data, the number and type of prompts necessary for the caregiver to open the electronic pillbox can be determined. In case the young adult does not open the electronic pillbox within two hours, the caregiver will be notified so that pills are not missed. In each step, the useful features of the system will be determined via qualitative and quantitative feedback with specific suggestions about how to improve this supportive system.
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
-
-
Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
-
-
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:
For young adult:
- Diagnosed with cerebral palsy or spina bifida and previously enrolled in HUM00081812
- Age 18-26 years-old
- Having mild-moderate cognition based on consultation with the investigators and the results of the following tests: iBRIEF Metacognition index T-Score, CVLT List A Free Recall T Score, ReyO Organization T-Score, PPVT Scaled Score, Tower Scaled Score, TRAQ question 4: Do participants take medications correctly and on their own?
- Having adequate physical dexterity (to be able to open a pill box and use an iPad/tablet)
- Taking two or more routine oral medicines in pill formulation
- Being able to take capsules or tablets
- Still living at home with their parent/legal guardian
- Have Wi-Fi/Internet access at home
For parent/caregiver:
- Being the parent/legal guardian of a person with aforementioned disability
- Owning a cell phone
- Have Wi-Fi/Internet access at home
Exclusion Criteria:
• Those who do not fulfill the inclusion criteria will be excluded from the study
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：デバイスの実現可能性
- 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：RL-adaptive application
Dyad is comprised of individual with disability (spina bifida or cerebral palsy) and the respective parent/legal guardian (also referred to as caregivers). Young adult will use the RL-adaptive support application that the investigators are developing to help manage medications. |
Up to 6 dyads of individuals with disabilities and their caregivers will be recruited to collaborate in defining the features and content of the RL-adaptive support. The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each:
The goal is to reduce the number of caregiver prompts necessary for the medication pillbox to be opened. |
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 |
|---|---|---|
|
Prefer to continue to use RL-adaptive support after study is over
時間枠：at least 18 weeks after beginning study
|
Qualitative feedback
|
at least 18 weeks after beginning study
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Usefulness of the aspects of the RL-adaptive support
時間枠：End of each phase, which lasts approximately 6 weeks
|
Qualitative feedback
|
End of each phase, which lasts approximately 6 weeks
|
|
Most and least helpful aspects of RL-adaptive support application
時間枠：End of each phase, which lasts approximately 6 weeks
|
Qualitative feedback
|
End of each phase, which lasts approximately 6 weeks
|
|
Ease of use of RL-adaptive support application
時間枠：End of each phase, which lasts approximately 6 weeks
|
Qualitative feedback
|
End of each phase, which lasts approximately 6 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Karen B Farris, PhD、Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
その他の研究ID番号
- HUM00107874 and HUM00139267
- 90RE5012 (その他の助成金/資金番号：NIDILRR)
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。
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