NP-Supported Multidisciplinary Diabetes Management During Perioperative Period (NPMDM-PP)
14. März 2022 aktualisiert von: Peking University Third Hospital
NP-Supported Multidisciplinary Diabetes Management During Perioperative Period in Patient With Diabetes Mellitus
The primary objective of this study is to determine the benefits of interventions from a Multidisciplinary Diabetes Care team involved of diabetes nurse practitioners(DNP) on glucose control, perioperative outcomes and psychosocial outcomes for patients with Diabetes Mellitus
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
About 50% of diabetic patients will undergo at least one surgical operation, and nearly 20% of surgical patients have diabetes.Compared with non-diabetic patients, diabetic patients face greater risks during the perioperative period. Stress factors such as preoperative preparation, anesthesia, surgical trauma, pain, drugs and negative emotions can induce blood glucose fluctuations, which could lead to complications such as hyperglycemia, diabetic ketosis, and hypoglycemia.Therefore, perioperative management has become an important part of diabetes management.
A multidisciplinary collaborative team led by NP can reduce the mortality of patients after inpatient surgery, help patients change their lifestyle, maintain self-management behavior, improve patient experience, and reduce hospitalization costs. This study intends to explore the application effect of NP-led multidisciplinary collaborative team in the perioperative comprehensive management of diabetic patients.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
170
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Qun Wang
- Telefonnummer: 13901280942
- E-Mail: wq3025@sina.com
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Diagnosis meets World Health Organization (WHO) (1999) Diabetes Diagnostic Standards
- Orthopedic assessment requires elective surgery and no surgical contraindications
- HbA1c≥8.5% or intravenous fasting blood glucose (FBG)>10mmol/l
- Informed consent.
Exclusion Criteria:
- Cognitive and communication disorders;
- Pregnancy;
- Participate in other intervention studies.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: NP-Supported Multidisciplinary Diabetes Management
NP establishes files to evaluate and manage patients before hospital and visits patients after hospitalization.
Then set blood glucose control goals with endocrinology and orthopedic doctors together, initiates consultation with endocrinologists for patients with postoperative hyperglycemia, and is responsible for post-hospital follow-up.
|
NP establishes files to evaluate and manage patients before hospital and visits patients after hospitalization.
Then set blood glucose control goals with endocrinology and orthopedic doctors together, initiates consultation with endocrinologists for patients with postoperative hyperglycemia, and is responsible for post-hospital follow-up.
|
|
Kein Eingriff: Regular diabetes management
The patient would go to the endocrinology outpatient clinic before hospitalization to regulate blood glucose, and be managed by by orthopedic medical staff through hospitalization.
If necessary, the endocrinologist is consulted.
And after the hospital, patients would be followed up by orthopedic medical staff.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
EFFICACY: TIR（Time in Range）
Zeitfenster: From into the group to the first hospital day; First day in hospital to the day of discharge
|
Time in range
|
From into the group to the first hospital day; First day in hospital to the day of discharge
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
EFFICACY: Glycated Serum Protein
Zeitfenster: baseline and 1 month after discharged
|
Glycated Serum Protein would be conducted to measure glucose control
|
baseline and 1 month after discharged
|
|
EFFICACY: Incidence of perioperative hypoglycemia
Zeitfenster: From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
|
Incidence of perioperative hypoglycemia would be conducted to measure glucose control
|
From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
|
|
EFFICACY: Time required for blood glucose standard before surgery
Zeitfenster: the first hospital day
|
The time from the patient's enrollment to the blood glucose reaching the blood glucose control target
|
the first hospital day
|
|
EFFICACY: Diabetes self-management behavior
Zeitfenster: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
|
measured by Summary of Diabetes Self-Care Activities（SDSCA）.
SDSCA scores from 0 to 77 and higher score means better self-management behaviors.
|
Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
|
|
EFFICACY: Incidence of perioperative adverse events
Zeitfenster: 1 month after discharge
|
Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.
|
1 month after discharge
|
|
EFFICACY: Blood pressure
Zeitfenster: baseline, day of hospitalization, during hospitalization and 1 month after discharge
|
A calibrated electronic blood pressure meter of the same brand was used to measure systolic pressure and diastolic pressure in the same arm at the same time daily
|
baseline, day of hospitalization, during hospitalization and 1 month after discharge
|
|
EFFICACY: Body weight
Zeitfenster: baseline, day of hospitalization, during hospitalization and 1 month after discharge
|
The same scale was used to measure after patients got up in the morning.
|
baseline, day of hospitalization, during hospitalization and 1 month after discharge
|
|
EFFICACY: Anxiety and depression
Zeitfenster: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
|
measured by Hospital Anxiety and Depression Scale (HADS) scale.
HADS contains two subscales: anxiety and depression, and each subscale have 7 items.
Total scores were from 0 to 42(anxiety: 21 scores; depression: 21 scores), higher score means more severe anxiety and/or depression.
|
Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
|
|
QUALITY OF LIFE:living quality
Zeitfenster: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
|
measured by Short Form 36 Health Survey (SF-36) which contains 8 modules with different score formula.
Higher total scores mean better living quality.
|
Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Golden SH, Peart-Vigilance C, Kao WH, Brancati FL. Perioperative glycemic control and the risk of infectious complications in a cohort of adults with diabetes. Diabetes Care. 1999 Sep;22(9):1408-14. doi: 10.2337/diacare.22.9.1408.
- Liao CC, Lin CS, Shih CC, Yeh CC, Chang YC, Lee YW, Chen TL. Increased risk of fracture and postfracture adverse events in patients with diabetes: two nationwide population-based retrospective cohort studies. Diabetes Care. 2014 Aug;37(8):2246-52. doi: 10.2337/dc13-2957. Epub 2014 May 7. Erratum In: Diabetes Care. 2017 Jun 14;:
- Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. doi: 10.2337/diacare.27.2.553. No abstract available. Erratum In: Diabetes Care. 2004 Mar;27(3):856. Hirsh, Irl B [corrected to Hirsch, Irl B]. Diabetes Care. 2004 May;27(5):1255.
- Meneghini LF. Perioperative management of diabetes: translating evidence into practice. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S53-9. doi: 10.3949/ccjm.76.s4.09.
- Sebranek JJ, Lugli AK, Coursin DB. Glycaemic control in the perioperative period. Br J Anaesth. 2013 Dec;111 Suppl 1:i18-34. doi: 10.1093/bja/aet381.
- Aminian A, Kashyap SR, Burguera B, Punchai S, Sharma G, Froylich D, Brethauer SA, Schauer PR. Incidence and Clinical Features of Diabetic Ketoacidosis After Bariatric and Metabolic Surgery. Diabetes Care. 2016 Apr;39(4):e50-3. doi: 10.2337/dc15-2647. Epub 2016 Jan 28. No abstract available.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. April 2022
Primärer Abschluss (Voraussichtlich)
31. März 2023
Studienabschluss (Voraussichtlich)
31. März 2023
Studienanmeldedaten
Zuerst eingereicht
29. Dezember 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. März 2022
Zuerst gepostet (Tatsächlich)
23. März 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
23. März 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. März 2022
Zuletzt verifiziert
1. Dezember 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- M2021609
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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