Itaca App vs. Usual Care for Medication Adherence in Older Adults on Polypharmacy
Monitoring Medication Adherence in Patients Aged ≥65 Years on Polypharmacy: A Randomized Clinical Trial of the Itaca Mobile App vs. Usual Care
The goal of this clinical trial is to learn if the use of a mobile app called Itaca improves medication adherence in older adults (aged ≥65) in a home care setting. It will also assess the impact of the app on patient engagement, patient activation, quality of life, and the app's usability in the intervention group. The main question it aims to answer is:
- Does the use of the Itaca mobile application improve medication adherence among older adults in the home care setting compared with usual care?
- Does the use of the Itaca mobile application improve patient engagement, patient activation, and quality of life among older adults in the home care setting compared with usual care?
Researchers will compare usual care to see if the intervention using the Itaca mobile app is more effective in improving medication adherence.
Participants will:
- In the intervention group, use the Itaca app for 3 months
- In the intervention group, receive monthly phone calls to support adherence to the study protocol, monitor app use, and address any barriers
- In the intervention group, complete the usability scale at the end of the 3-month intervention period
- In both the intervention and control groups, complete the questionnaires at enrollment and after 3 months, at the end of the intervention period
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Lazio
-
Rome、Lazio、イタリア、00100
- Local Health Unit
-
-
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥ 65 years with chronic condition
- Taking three or more medications regardless of route of administration
- Able to understand and speak Italian and to adhere to the study by signing written informed
- Able to understand and speak Italian and to adhere to the study by signing written informed
Exclusion Criteria:
- Pediatric or adult (< 65 years)
- Taking fewer than three medications
- With diagnosed cognitive impairment or psychiatric disorder that could interfere with participation in 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：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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention group: Itaca app mobile
|
At baseline (T0), the research team will support participants in installing the ITACA application on their personal smartphone. An individual training session will be provided at T0. Medication reminder notifications will be activated according to each patient's prescribed regimen. The application will be used throughout the entire 3-month follow-up period. Researchers will contact participants by telephone at monthly intervals to monitor app use and address barriers. No formal assessments are performed at these contacts. At 3 months (T1), participants will complete the System Usability Scale (SUS) (subject to prior authorization and/or licensing for use) to evaluate perceived app usability. |
|
アクティブコンパレータ：Control group: Usual Care
|
At baseline (T0), participants will receive and be provided with an explanation of a written medication plan containing prescribed therapies, dosages, and administration schedules. Participants will continue standard clinical follow-up with their GP throughout the 3-month period. No digital tools or additional interventions will be provided beyond routine clinical practice. |
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 |
|---|---|---|
|
Change in Medication Adherence Score Levels
時間枠：From enrollment to end of treatment at 3 months
|
Primary outcome is the change in adherence level measured by the Morisky Medication Adherence Scale (MMAS-4), subject to prior authorization and/or licensing for use.
|
From enrollment to end of treatment at 3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Patient Health Engagement Score Levels
時間枠：From enrollment to 3 months
|
Change in patient health engagement score measured by the PHE-s, subject to prior authorization and/or licensing for use.
|
From enrollment to 3 months
|
|
Change in Health-Related Quality of Life Score Levels
時間枠：From enrollment to 3 months
|
Change in health-related quality of life score measured by the SF-12, subject to prior authorization and/or licensing for use.
|
From enrollment to 3 months
|
|
App Usability Score Levels
時間枠：At the end of the intervention period, with a duration of 3 months
|
Usability measured by the System Usability Scale (SUS), subject to prior authorization and/or licensing for use, assessed only in the intervention group
|
At the end of the intervention period, with a duration of 3 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 7889 (CTEP)
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?
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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