A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Chang Gung Memorial Hospital
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Yea-Ing Lotus Shyu, Chang Gung University
ClinicalTrials.gov Identifier:
NCT01051830
First received: January 17, 2010
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to 1) develop a well-conceived and feasible protocol for hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2) compare the costs and effectiveness of this DM-specific model with those of an effective subacute care model previously developed by our research team.


Condition Intervention Phase
Diabetes Mellitus
Hip Fracture
Other: Diabetes interdisciplinary program
Other: Rehabilitation program, nursing care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Activities of Daily life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 264
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interdisciplinary group
Diabetes intervention and rehabilitation program
Other: Diabetes interdisciplinary program
Diabetes consulting, rehabilitation program
Other Name: Diabetes interdisciplinary program
No Intervention: Control group
Sham Comparator: Subacute group
Only apply rehabilitation program
Other: Rehabilitation program, nursing care
Rehabilitation program, nursing care
Other Name: Rehabilitation program, nursing care

Detailed Description:

Clinical and scientific significance. Health outcomes, as well as physical and cognitive function, have been shown to be negatively impacted by comorbidity beyond the bare sum of effects due to the single diseases. One such comorbidity is diabetes mellitus (DM), a global health issue and the fifth major cause of death in Taiwan from 1987 to 2001. Starting in 2002, DM has become the fourth. Hip-fractured elderly persons with DM were shown in our previous studies to have significantly higher mortality and readmission rates and poorer recovery in walking ability and various physical health outcomes than those without DM during the first year after discharge. Clinical evidence has shown that elderly patients with hip fracture can benefit from postoperative rehabilitation, early discharge-planning programs, or transitional care programs. However, little is known about effective interventions specifically for hip fractured patients with DM.

Research Purposes. The purpose of this study is to 1) develop a well-conceived and feasible protocol for hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2) compare the costs and effectiveness of this DM-specific model with those of an effective subacute care model previously developed by our research team.

Data and Methods. A clinical trial with 1-year follow-up will be used to compare the cost-effectiveness of the DM-specific model in 88 hip-fractured elderly patients with that of our subacute care model (n=88) and routine care (n=88). Patients will be recruited through the emergency room of Chang Gung Memorial Hospital (CGMH) at Lin Kuo. Subjects will be assessed before surgery, before discharge, at 1, 3, 6, and 12 months after discharge for biometric measures, DM-related outcomes, clinical outcomes, self-care ability, health-related quality of life, service utilization, and costs of care. To maximize outcomes sensitive to the intervention, biometric measures of activity will be included, i.e., daily energy consumption and arterial stiffness index. DM-related variables will include haemoglobin A1c (HbA1c), tendon reflexes, superficial and deep sensation, peripheral pulses, diabetic retinopathy, signs of "diabetic foot," use of medication, and clinical procedures. The study has already been approved by the Institutional Review Board of CGMH. Trajectories of the outcome variables and their predictors will be analyzed by the generalized estimating equations (GEE) approach. The cost of the three care models will also be compared. Findings of this study can contribute to current knowledge and practice for elderly patients with DM recovering from hip-fracture surgery.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 60 years or older (this criterion is based on our previous NHRI-funded study: Intervention program for elderly patients with hip fracture, 2001-2003),
  2. Diagnosed with DM,
  3. Admitted to CGMH from its emergency room due to hip fracture, and
  4. Living in northern Taiwan (i.e.,greater Taipei area, Keelung, Taoyuan, or Shin-Ju Province).

Exclusion Criteria:

  1. Clinical diagnosis of Cancer
  2. Can't communicate with researchers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051830

Contacts
Contact: Yueh-Fang Huang, Master +886-3-2118999 ext 3203 yfhuang@mail.cgit.edu.tw

Locations
Taiwan
Chang Gung Memorial Hospital, Taiwan Recruiting
Taipei, Taoyuan, Taiwan
Contact: Yueh-Fang Huang, Master    +886-3-2118999 ext 3203    yfhuang@mail.cgit.edu.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Yea-Ing L Shyu, PhD Chang Gung University
  More Information

No publications provided

Responsible Party: Yea-Ing Lotus Shyu, Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT01051830     History of Changes
Other Study ID Numbers: 98-0327B-P04I99N, CGMH-98-0327B
Study First Received: January 17, 2010
Last Updated: February 10, 2012
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Hip Fractures
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 29, 2014