FAMS を適応させて 1 型糖尿病の新興成人における CGM の使用を最適化する
The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).
Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90027
- Children's Hospital of Los Angeles
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84112
- University of Utah
-
-
参加基準
適格基準
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:
PERSONS WITH DIABETES
- Ages 18-24
- Have a diagnosis of T1D and has been taking insulin for at least one year
- Comfortable sending and receiving texts
- Can speak, read, and write in English
- Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
- Using a continuous glucose monitor (CGM)
SUPPORT PERSONS
- Age 18 or older
- Can speak, read, and write in English or Spanish
- Comfortable sending and receiving texts
Exclusion Criteria:
PERSONS WITH DIABETES
- Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
- Plans to live outside the country during the study period
SUPPORT PERSONS
- Shares a phone with the person with diabetes
- Plans to live outside of the country during the study period
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：FAMS-T1D
Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled. Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.
他の名前：
Quality digital resources about diabetes management provided upon enrollment and during the study. |
|
プラセボコンパレーター：Digital resources for diabetes
All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
Quality digital resources about diabetes management provided upon enrollment and during the study. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CGM frequency of use during the intervention period
時間枠：Baseline and 6 months post-baseline
|
Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better |
Baseline and 6 months post-baseline
|
|
CGM frequency of use during the intervention period
時間枠：Baseline and 6 months post-baseline
|
Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better) |
Baseline and 6 months post-baseline
|
|
Gaps in CGM use
時間枠：6 months post-baseline
|
Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse) |
6 months post-baseline
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CGM behavioral responses during the intervention period
時間枠：Baseline and 6 months post-baseline
|
Change in frequency of making behavioral changes in response to CGM data assessed by self-report; higher scores indicate more frequent response (better) |
Baseline and 6 months post-baseline
|
|
Barriers to CGM use during the intervention period
時間枠：Baseline and 6 months post-baseline
|
Change in perceived influence of CGM on glycemic control scale assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) |
Baseline and 6 months post-baseline
|
|
Barriers to CGM use during the intervention period
時間枠：Baseline and 6 months post-baseline
|
Change in perceived influence of CGM on social complications assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) |
Baseline and 6 months post-baseline
|
|
CGM satisfaction during the intervention period
時間枠：Baseline and 6 months post-baseline
|
Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better) |
Baseline and 6 months post-baseline
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Data sharing during the intervention period
時間枠：6 months post-baseline
|
Number of data sharing relationships, between groups; more is better |
6 months post-baseline
|
|
Satisfaction with data-sharing relationships
時間枠：6 months post-baseline
|
Satisfaction with data-sharing relationships assessed by CGM-Satisfaction Scale; higher scores are better |
6 months post-baseline
|
協力者と研究者
協力者
協力者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 220847
- G-2203-05822 (その他の助成金/資金番号：The Leona M. and Harry B. Helmsley Charitable Trust)
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
After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
IPD 共有時間枠
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
IPD 共有アクセス基準
Contact the principal investigator
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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。