| 基本情報/Basic information |
| 一般向け試験名/Public title |
糖尿病腎症重症化予防のための遠隔モニタリング指導の実用可能性と疾病管理効果の検証 |
Evaluation of feasibility and effects of the distant interview program for preventing the progression of diabetic nephropathy |
| 一般向け試験名略称/Acronym |
糖尿病腎症に対する遠隔モニタリング指導の実用可能性と効果の検証 |
Evaluation of feasibility and effects of the distant interview program for patients with diabetic nephropathy |
| 科学的試験名/Scientific Title |
糖尿病腎症重症化予防のための遠隔モニタリング指導の実用可能性と疾病管理効果の検証 |
Evaluation of feasibility and effects of the distant interview program for preventing the progression of diabetic nephropathy |
| 科学的試験名略称/Scientific Title:Acronym |
糖尿病腎症に対する遠隔モニタリング指導の実用可能性と効果の検証 |
Evaluation of feasibility and effects of the distant interview program for patients with diabetic nephropathy |
| 試験実施地域/Region |
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| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
セルフマネジメント指標：Prochaska (1983)の行動変容ステージモデルを参考に食事、運動、薬物療法、セルフモニタリングの５段階の指標を作成した。 |
Self-management indicators: A 5-points scale based on the model of behavioral change suggested by Prochaska (1983) is developed to evaluate self-management behavior for diet, excercise, medication and self-monitoring. |
| 副次アウトカム評価項目/Key secondary outcomes |
１）身体的指標：血清クレアチニン、推測糸球体濾過量、血清尿素窒素、ヘモグロビン、総蛋白、アルブミン、カリウム、リン、HbA1c、non HDLコレステロール、血圧、ＢＭＩ、尿蛋白。CKDステージ、透析導入や心血管イベント発症した者の数。
２）心理学的指標：自己効力感（慢性疾患患者の健康行動に対するセルフエフィカシー尺度）、QOL（WHO-QOL26全体的QOLを示す２項目の平均点。
３）実用可能性：看護師との信頼関係、行動変容への動機づけ、音声や画像の鮮明性（遠隔指導のみ）、デバイスの操作性と指導方法（遠隔指導のみ）、プライバシー保護
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1) Physical indicators: Serum creatinine, estimated glomerular filtration rate, blood urea nitrogen, hemoglobin, total protein, albumin, potassium, inorganic phosphate, HbA1c, non-high-density lipoprotein cholesterol, blood pressure, body mass index, and urine protein. The change of CKD stage, number of participants initiating dialysis, and number of participants with cardiovascular events were used as parameters.
2) Psychological indicators: The self-efficacy scale of health behavior in patients with chronic disease and the mean values of 2 items for global QOL in the World Health Organization Quality of Life (WHO-QOL26) scale, Japanese version.
3) Feasibility: Trusting the nurse, Motivation for behavioral change, Correctness of information, Clarity of images or sound (distance interview only), Operability of the device and interview method (distance interview only), Protection of privacy. |
| 介入/Intervention |
| 群数/No. of arms |
2 |
| 介入の目的/Purpose of intervention |
教育・カウンセリング・トレーニング/Educational,Counseling,Training |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
タブレット端末を利用した遠隔面談と電話指導を実施したプログラム；１ヶ月目～3ヶ月目まで月１回、約1時間のタブレット端末を使用した遠隔面談を合計3回、約30分間の電話指導を2週間ごとに合計9回実施する。指導の内容は、糖尿病及びCKD診療ガイドラインに基づいた内容で、初回面談時に検査データからCKDステージを判断し、検査データと治療内容、身体診査の所見、日常生活の聴き取り（詳細な食事内容を含む）からリスクファクターを特定し、患者にテキストを用いて糖尿病性腎症の病態、療養管理方法の知識提供を行った後に、具体的な生活改善について患者と話し合い、目標設定を行う。その後、患者は自宅で、血圧、体重、血糖値の自己測定を行い自己管理手帳に記載、内服・受診等の治療遵守、看護師と設定した行動目標に沿った食事や運動療法を実施し、毎月、看護師に報告する。タブレット端末は、開発した指導のアプリケーションを内蔵し、対象者に郵送し、貸し出した。テキストは内蔵に加えて、自己管理手帳やモノフィラメントと一緒に送付する。 |
The program implemented by distance interviews using a tablet computer and intermittent telephone calls. In Months 1 to 3, individual distance interviews about 1 hour long were held once a month using a tablet computer and biweekly follow up education calls were given via telephone for about 30 minutes. Education was provided based on the evidence based clinical guidelines for Diabetes and for CKD. The CKD stage was assessed at the initial interview based on laboratory data, while risk factors were identified based on laboratory data, treatment, and information obtained from physical examination and evaluation regarding the lifestyle. The nurses explained the pathology and management of diabetic nephropathy and discussed the goals for improvement of their lifestyles. Subsequently, each participant measured the blood pressure, body weight, and blood glucose level at home, recorded the results in a self monitoring notebook, took medications, periodically visited the clinic, and followed diet and exercise therapy as discussed to achieve the goals defined with assistance from the nurses. The results of implementation were reported to the nurses every month. The tablet with an application for instructions was delivered to the participants by postal mail. The guidebook was included in the app, but a paper version was also delivered to the participants by mail together with the self monitoring notebook and foot care monofilament.
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| 介入2/Interventions/Control_2 |
対面面談と電話指導を実施したプログラム；１ヶ月目～3ヶ月目まで月１回、プライバシーが保護できる職場か公共施設の個室で約1時間の対面による面談を合計3回、約30分間の電話指導を2週間ごとに合計9回実施する。テキスト、自己管理手帳、フットケア用のモノフィラメントは郵送した。 |
The program implemented by face to face interviews and intermittent telephone calls. In Months 1 to 3, individual face to face interviews about 1 hour long were held once a month in a private room at the workplace or at a public facility where the privacy of the participant could be protected, and biweekly follow up education calls were given via telephone for about 30 minutes. The guidebook, the self monitoring notebook, and monofilament for foot care were delivered by mail. |
| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
A企業健保被保険者であり、2013年の40歳以上を対象とした特定健診にて[1] 尿蛋白2+以上、または尿蛋白1+かつHbA1c 7.0%以上 (または 空腹時血糖 130 mg/dL以上) に該当する者、かつ[2]２型糖尿病と診断された者. |
Participants are employees of A company and fall the following:
[1] Urine protein 2+ or higher, or urine protein 1+ and HbA1c 7.0% and over (FBS 130 mg/dL and over) at a health check in 2013 (a special check for individuals aged 40 years or older) and [2] Diagnosed as type 2 diabetes. |
| 除外基準/Key exclusion criteria |
１型糖尿病
妊娠糖尿病
透析導入した者
直近で腎移植の予定がある者
がん治療中の者、
終末期の者
認知機能障害や精神障害を有する者 |
Exclusion criteria are the following: type 1 diabetes or gestational diabetes, initiated to dialysis, scheduled for renal transplantation in the near future, undergoing treatment for cancer, terminal illness, cognitive impairment, and mental disorders. |
| 目標参加者数/Target sample size |
140 |
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