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NP-Supported Multidisciplinary Diabetes Management During Perioperative Period (NPMDM-PP)

Primary Purpose

Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NP-Supported Multidisciplinary Diabetes Management
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring nurse practitioners, Multidisciplinary Diabetes Management, perioperative period

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    NP-Supported Multidisciplinary Diabetes Management

    Regular diabetes management

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    EFFICACY: TIR(Time in Range)
    Time in range

    Secondary Outcome Measures

    EFFICACY: Glycated Serum Protein
    Glycated Serum Protein would be conducted to measure glucose control
    EFFICACY: Incidence of perioperative hypoglycemia
    Incidence of perioperative hypoglycemia would be conducted to measure glucose control
    EFFICACY: Time required for blood glucose standard before surgery
    The time from the patient's enrollment to the blood glucose reaching the blood glucose control target
    EFFICACY: Diabetes self-management behavior
    measured by Summary of Diabetes Self-Care Activities(SDSCA). SDSCA scores from 0 to 77 and higher score means better self-management behaviors.
    EFFICACY: Incidence of perioperative adverse events
    Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.
    EFFICACY: Blood pressure
    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
    EFFICACY: Body weight
    The same scale was used to measure after patients got up in the morning.
    EFFICACY: Anxiety and depression
    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.
    QUALITY OF LIFE:living quality
    measured by Short Form 36 Health Survey (SF-36) which contains 8 modules with different score formula. Higher total scores mean better living quality.

    Full Information

    First Posted
    December 29, 2021
    Last Updated
    March 14, 2022
    Sponsor
    Peking University Third Hospital
    Collaborators
    Roche Pharma AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05293015
    Brief Title
    NP-Supported Multidisciplinary Diabetes Management During Perioperative Period
    Acronym
    NPMDM-PP
    Official Title
    NP-Supported Multidisciplinary Diabetes Management During Perioperative Period in Patient With Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    March 31, 2023 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital
    Collaborators
    Roche Pharma AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes
    Keywords
    nurse practitioners, Multidisciplinary Diabetes Management, perioperative period

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NP-Supported Multidisciplinary Diabetes Management
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Regular diabetes management
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    NP-Supported Multidisciplinary Diabetes Management
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    EFFICACY: TIR(Time in Range)
    Description
    Time in range
    Time Frame
    From into the group to the first hospital day; First day in hospital to the day of discharge
    Secondary Outcome Measure Information:
    Title
    EFFICACY: Glycated Serum Protein
    Description
    Glycated Serum Protein would be conducted to measure glucose control
    Time Frame
    baseline and 1 month after discharged
    Title
    EFFICACY: Incidence of perioperative hypoglycemia
    Description
    Incidence of perioperative hypoglycemia would be conducted to measure glucose control
    Time Frame
    From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
    Title
    EFFICACY: Time required for blood glucose standard before surgery
    Description
    The time from the patient's enrollment to the blood glucose reaching the blood glucose control target
    Time Frame
    the first hospital day
    Title
    EFFICACY: Diabetes self-management behavior
    Description
    measured by Summary of Diabetes Self-Care Activities(SDSCA). SDSCA scores from 0 to 77 and higher score means better self-management behaviors.
    Time Frame
    Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
    Title
    EFFICACY: Incidence of perioperative adverse events
    Description
    Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.
    Time Frame
    1 month after discharge
    Title
    EFFICACY: Blood pressure
    Description
    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
    Time Frame
    baseline, day of hospitalization, during hospitalization and 1 month after discharge
    Title
    EFFICACY: Body weight
    Description
    The same scale was used to measure after patients got up in the morning.
    Time Frame
    baseline, day of hospitalization, during hospitalization and 1 month after discharge
    Title
    EFFICACY: Anxiety and depression
    Description
    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.
    Time Frame
    Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
    Title
    QUALITY OF LIFE:living quality
    Description
    measured by Short Form 36 Health Survey (SF-36) which contains 8 modules with different score formula. Higher total scores mean better living quality.
    Time Frame
    Measurements were taken at baseline, day of hospitalization, and 1 month after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qun Wang
    Phone
    13901280942
    Email
    wq3025@sina.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24804698
    Citation
    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;:
    Results Reference
    background
    PubMed Identifier
    19880837
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    14747243
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24335396
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26822327
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10480501
    Citation
    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.
    Results Reference
    background

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    NP-Supported Multidisciplinary Diabetes Management During Perioperative Period

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