Mobile Health Intervention for Improved Adherence in Type 2 Diabetes
2022年3月22日 更新者：Madu Ihekoronye、Obafemi Awolowo University
Evaluation of mHealth Intervention to Improve Medication Adherence in Type 2 Diabetes in Nigeria: a Randomized Controlled Trial
The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices.
Patients' clinic attendance and pharmacy refill records were reviewed for the period of 1 year.
Then over a period of 1 month, newly diagnosed T2D patients were enrolled in the prospective phase of the study and randomized into control and intervention groups.
A mobile phone-based health education and follow-up package was applied to the intervention group alone for a period of 6 months.
Afterwards, both groups were assessed and compared on the study outcome parameters.
Same questionnaires were used pre- and post-intervention for primary data collection.
Descriptive and inferential statistics were used for data analysis.
調査の概要
詳細な説明
Objectives of the Study: The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices.
Study design: Randomized controlled trial Study Setting: Diabetes Clinic, Endocrinology Unit, Department of Internal Medicine, Obafemi Awolowo University Teaching Hospital Ile Ife, Osun State Nigeria The study was structured in five stages. Study Duration: Seven months Stage 1: Baseline data Task 1: Baseline data for patients' glycemic control were obtained from one-year retrospective review of 1392 patients' files for glycated haemoglobin (HbA1c) measurements.
Task 2: Patients' baseline adherence data were obtained from one-year retrospective review of pharmacy refill records (clinic attendance) Task 3: Development and validation of research instruments (Questionnaires, Short Message Services (SMS).
Task 4: Recruitment and training of research assistants (2 hours daily for 3 days) Stage 2: Recruitment and randomization of participants Task 1: Enrolment of all newly-diagnosed patients (n = 120), enrolled in the Diabetes Clinic in the period of one month following Stage 1 Task 2: Obtaining of informed consent from all newly-diagnosed patients enrolled in the Diabetes Clinic in the one month following Stage 1 Task 3: Collection of participants' baseline knowledge data using structured questionnaire Task 4: Collection of baseline self-reported adherence data using the adapted 8-point Morisky Medication Adherence Scale (MMAS-8) instrument Task 5: Randomization of consenting participants into two equal (n = 60) control and intervention groups using a randomization software Stage 3: Intervention Task 1: Activation of short message services to participants in the intervention cohort at a frequency of one message per day for the period of 6 months.
Task 2: Follow up on clinic attendances of all participants for the period of 6 months Stage 4: Post-Intervention Review Task 1: Repeat administration of same questionnaires originally administered at Stage 2 to all participants Task 1: Review of participants' clinic attendance and pharmacy refill records Task 2: Review of participants HbA1c measurements from their records Stage 5: Data analysis Task 1: Demographic variables of participants were analyzed using descriptive statistics including frequency and percentages Task 2: Weighted mean scores were used to analyze knowledge and adherence scores Task 3: Two-sample t-test was used to compare pre- and post-intervention scores of knowledge and adherence Task 4: Chi square test was conducted to analyze associations between demographic variables and self-reported adherence data Task 5: Statistical package for the social sciences (SPSS) version 21 for windows software was used for data analysis at the p < 0.05 level of significance
研究の種類
介入
入学 (実際)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Osun
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Ile Ife、Osun、ナイジェリア、234
- Obafemi Awolowo University Teaching Hospital Complex
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Diagnosed of type 2 diabetes for the first time in the month following baseline study
- Male or female, 18 yeas of age and above
- Enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Gave informed consent to participate.
Exclusion Criteria:
- Diagnosed of other disease conditions outside type 2 diabetes
- Below 18 years of age
- Not enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Did not give informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：control group
Type 2 diabetes patients, 18 years old and above, enrolled in the out-patient, diabetes clinic of the tertiary health facility, receiving only standard of care, and who gave their informed consent
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実験的：intervention group
type 2 diabetes patients, 18 years old and above, enrolled in the out-patient diabetes clinic of the tertiary health facility, receiving standard of care in addition to a mobile phone - based health education and follow-up messaging on a frequency of once a day corresponding to how often they are expected to take their medications (that is every day), and who gave their informed consent.
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health education and follow-up messaging, randomly assigned to each participant in the intervention arm using a randomization software, delivered once daily, as short message service (sms)
他の名前：
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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 |
|---|---|---|
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Primary outcome measure
時間枠：6 Months
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Reduction in glycated hemoglobin (HbA1c), measured using blood tests, expressed in mmol/mol (%)
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6 Months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Secondary outcome measure I
時間枠：6 months
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Knowledge of diabetes, measured as by the mean score of participants in a questionnaire-based survey
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6 months
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Secondary outcome measure II
時間枠：6 months
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Adherence to medication, measured by the mean score of participants in a questionnaire-based survey
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Kanayo Osemene, Ph.D.、Department of Clinical Pharmacy and Pharmacy Administration, Obafemi Awolowo University, Ile Ife Nigeria
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年12月15日
一次修了 (実際)
2019年7月1日
研究の完了 (実際)
2019年7月1日
試験登録日
最初に提出
2022年3月14日
QC基準を満たした最初の提出物
2022年3月14日
最初の投稿 (実際)
2022年3月22日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月4日
QC基準を満たした最後の更新が送信されました
2022年3月22日
最終確認日
2022年3月1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。