NCT05721599

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of innovative integrated care in pre-frail or frail patients with diabetes over 65 years old. The main questions it aims to answer are:

  • To establish innovative integrated care for frail elderly patients with diabetes combined with nutrition and lifestyle guidance.
  • To evaluate the effectiveness of the intervention compared with general outpatient care. Participants will receive 12 weeks of structured care including specialist care, integrated assessment, group health education, one-on-one nutrition and lifestyle guidance, online and face-to-face support group, and case management. Researchers will compare general outpatient care to see its effects on frailty, physical function, and blood sugar control.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

February 1, 2023

Last Update Submit

August 5, 2024

Conditions

FrailtyDiabetesLifestyle

Keywords

FrailtyDiabetesOlder adultIntegrated careNutritionLifestyle

Outcome Measures

Primary Outcomes (24)

  • Changes from baseline frailty

    measured by Clinical Frailty Scale, max: 9, min: 1; higher score means worse outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline frail status

    measured by Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight scale; max: 5, min: 0; higher score means worse outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline activities of daily living

    measured by Barthel Index, max: 100, min: 0; higher score means better outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from instrumental activities of daily living

    measured by Instrumental Activities of Daily Living, max: 8, min: 0; higher score means better outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline cognition

    measured by Mini-Mental Status Examination, max: 30, min: 0; higher score means better outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline depression

    measured by Geriatric Depression Scale, max: 15, min 0; higher score means worse outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline nutritional status

    measured by Mini-Nutritional Assessment-Short Form, max: 14, min: 0; higher score means better outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline fall risk assessment

    measured by fall risk assessment

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline risk of sarcopenia

    measured by SARC-CalF, max: 20, min: 0; higher score means worse outcome

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline physical activity

    measured by International Physical Activity Questionnaire

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline quality of life

    measured by Likert 7-point

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline muscle strength measure by hand grip strength

    measured by hand grip strength

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline walking speed

    measured by six-meter walking speed

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Changes from baseline physical performance

    measured by Short Physical Performance Battery

    baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Change from baseline percentage of glycated hemoglobin (HbA1c)

    Change from baseline percentage of glycated hemoglobin (HbA1c)

    baseline, 12 weeks, 24 weeks

  • Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)

    Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)

    baseline, 12 weeks, 24 weeks

  • Change from baseline concentration of triglycerides

    Change from baseline concentration of triglycerides

    baseline, 12 weeks, 24 weeks

  • Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)

    Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)

    baseline, 12 weeks, 24 weeks

  • Change from baseline concentration of total cholesterol

    Change from baseline concentration of total cholesterol

    baseline, 12 weeks, 24 weeks

  • Change from baseline body weight

    Change from baseline body weight

    baseline, 12 weeks, 24 weeks

  • Change from baseline fat mass

    Change from baseline fat mass

    baseline, 12 weeks, 24 weeks

  • Change from baseline muscle mass

    Change from baseline muscle mass

    baseline, 12 weeks, 24 weeks

  • Change from baseline abdominal circumference

    Change from baseline abdominal circumference

    baseline, 12 weeks, 24 weeks

  • Change from baseline calf circumference

    Change from baseline calf circumference

    baseline, 12 weeks, 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Structured integrated care model

Behavioral: Integrated care with nutrition and lifestyle counselling

Control group

NO INTERVENTION

General outpatient care

Interventions

Integrated care with nutrition and lifestyle counsellingBEHAVIORAL

The structured care includes specialist care, integrated assessment, group health education, one-on-one nutrition and lifestyle guidance, online and face-to-face support group and case management.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • People aged 65 years or older.
  • People with Clinical Frailty Scale: 4-7.
  • People with a history of type II diabetes, use of diabetes medications, or HbA1c greater than or equal to 6.5%.
  • People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the following tracking.

You may not qualify if:

  • People that are unable to cooperate with or accept intervention or follow-up.
  • People with a history of type I diabetes.
  • People use insulin injections or pumps.
  • According to the PI's judgment, people with severe or poorly controlled conditions include acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.
  • People with severe visual or hearing impairment that prevent the completion of assessment and testing.
  • People with malignant tumors that have just been diagnosed or are undergoing treatment or are still at risk of recurrence.
  • People have received hormone therapy within three months before the trial or are expected to receive hormone therapy during the trial.
  • People are currently or expected to join any other physical training courses or nutrition plans during the trial.
  • Others are based on the judgment of the PI that participating in this trial may adversely affect the safety of the subjects, hinder the progress of the experiment, or interfere with the evaluation of the outcomes of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 97071, Taiwan

RECRUITING

MeSH Terms

Conditions

FrailtyDiabetes Mellitus

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Sheng-Lun Kao, MD.PhD.

    Buddhist Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Lun Kao, MD.PhD.

CONTACT

+886-3-8561825stevenkao7434@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

April 13, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)