Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05721599

Effectiveness of Integrated Care Combined Nutrition and Lifestyle Counselling in Frail Older Patients With Diabetes

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Frailty Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Lifestyle Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Tzu Chi General Hospital

Hualien City, 97071, Taiwan

Location status: Recruiting

Location contact

Sheng-Lun Kao, MD.PhD.

CONTACT

[email protected]

+886-3-8561825 ext. 15599

About this study

Frailty refers to a condition in which the body's reserves diminish with age, leading to a decreased ability to respond to stressors, making it difficult for individuals to maintain physiological stability and increasing susceptibility to diseases. The development of frailty often involves complex imbalances within the body's systems, such as the nervous system, endocrine system, immune system, and musculoskeletal system. Given the multifactorial nature of frailty, comprehensive assessments, and multifactorial interventions can improve functioning and reduce adverse outcomes in frail elderly individuals, including falls, hospitalization, or admission to nursing homes.

According to the American Diabetes Association guidelines, different A1c control targets can be established for elderly patients with diabetes based on their disease complexity, functionality, and cognitive status. Frailty, as a determinant of mortality in older adults, is also an important consideration in the treatment of diabetes. Furthermore, elderly patients with diabetes may experience a reduction in muscle strength and muscle mass, potentially leading to sarcopenia and subsequent frailty. Therefore, frailty and diabetes, two common health issues in the elderly, may mutually influence each other, altering the severity and treatment patterns of underlying diseases. Nutritional and lifestyle changes have the potential to slow down disability in frail elderly individuals with diabetes. While these recommendations are generally supported by guidelines, clinical evidence to support them is still needed. Past literature reviews have yet to conduct structured assessments of the effectiveness of nutritional and lifestyle guidance for frail elderly individuals with diabetes. Furthermore, in geriatric outpatient settings, a comprehensive integrated assessment should be used to establish treatment directions and plans for elderly patients with both frailty and diabetes, with ongoing monitoring.

In summary, aging is accompanied by disruptions in bodily systems, leading to the co-occurrence of frailty and diabetes, making them significant health issues during the aging process. Structured integrated care for frail elderly patients with diabetes, combining nutritional and lifestyle guidance, has the potential to reverse frailty, control blood sugar, and consequently delay disability. This study aims to investigate the effectiveness of innovative comprehensive assessments and care, including specialized care, integrated assessments, group health education, one-on-one nutritional and lifestyle guidance, online and face-to-face support group, and case management, on the improvement of frailty levels and blood sugar control in frail elderly patients with diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Integrated care with nutrition and lifestyle counselling

Behavioral

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.

Primary outcomes

  1. Changes from baseline frailty

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  2. Changes from baseline frail status

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  3. Changes from baseline activities of daily living

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  4. Changes from instrumental activities of daily living

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  5. Changes from baseline cognition

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  6. Changes from baseline depression

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  7. Changes from baseline nutritional status

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  8. Changes from baseline fall risk assessment

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

    measured by fall risk assessment

  9. Changes from baseline risk of sarcopenia

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

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

  10. Changes from baseline physical activity

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

    measured by International Physical Activity Questionnaire

  11. Changes from baseline quality of life

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

    measured by Likert 7-point

  12. Changes from baseline muscle strength measure by hand grip strength

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

    measured by hand grip strength

  13. Changes from baseline walking speed

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

    measured by six-meter walking speed

  14. Changes from baseline physical performance

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

    measured by Short Physical Performance Battery

  15. Change from baseline percentage of glycated hemoglobin (HbA1c)

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline percentage of glycated hemoglobin (HbA1c)

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

    Time frame: baseline, 12 weeks, 24 weeks

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

  17. Change from baseline concentration of triglycerides

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline concentration of triglycerides

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

    Time frame: baseline, 12 weeks, 24 weeks

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

  19. Change from baseline concentration of total cholesterol

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline concentration of total cholesterol

  20. Change from baseline body weight

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline body weight

  21. Change from baseline fat mass

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline fat mass

  22. Change from baseline muscle mass

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline muscle mass

  23. Change from baseline abdominal circumference

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline abdominal circumference

  24. Change from baseline calf circumference

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline calf circumference

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng-Lun Kao, MD.PhD.

CONTACT

[email protected]

+886-3-8561825 ext. 15599

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2023
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.