Clinical trial NCT06345118: Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Official title: Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Fall
Elderly Patient
Keywords: Falls prevention
Diabetes Mellitus type2
Elderly patient
Lead sponsor: National Geriatric Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: .This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are:

* Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients
* Evaluate the results of fall prevention and related factors in the study population.

Participants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities.

At the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests.

Detailed description: The proportion of the elderly population is increasing remarkably worldwide. The United Nations estimates there will be 727 million people aged 65 and older in 2020. According to the World Bank, Vietnam is one of the countries with the fastest population aging rate. Diabetes mellitus type 2 (T2DM) is a major public health problem, and the prevalence of T2DM increases exponentially with age. T2DM is also common in older people, and it has been estimated that approximately 25% of the patients with diabetes are over 65. There are an estimated 3.99 million people with diabetes aged 20-79 in 2021 in Vietnam, and this population will reach 6.01 million by 2045. Besides T2DM, the older adult is often faced with a myriad of health-related issues and problems, with falling being one primary concern for persons over 65 years of age. The high prevalence of falls in elderly individuals with DM is well established, with reported annual incidence rates up to 39%. Falls are linked to increased fracture risk and hospitalization for trauma. Recurrent falls can have a significant impact on social and physical activities, as well as quality of life. Falls cause about 2.8 million injuries treated in emergency departments annually, including over 800,000 hospitalizations and over 27,000 deaths. The entire cost of fall injuries in 2013 was $34 billion. The key to fall prevention is identifying persons at risk and implementing the appropriate intervention. Although there are standard fall prevention guidelines worldwide, such as those of the American Geriatrics Society or the British Geriatrics Society, in Vietnam, there are no specific guidelines for screening and preventing falls for older people. Besides, the lack of research on the rate of falls in older people in Vietnam creates a gap in optimizing treatment for elderly diabetes patients, especially when diabetes complications are one of the leading causes of increased fall rates. This study aims to evaluate the rate of falls in elderly diabetic patients treated as outpatients at a National Geriatric Hospital (NGH) and then conduct fall prevention interventions using the Otago Exercise Program (OEP) as the primary method. The study will be submitted and approved by the National Geriatric Hospital Ethics Committee and Hanoi Medical University Ethics Committee, Vietnam, and written consent was obtained from all participants.

Eligibility criteria: Inclusion Criteria:

For the first objective (Cross-sectional study):

* Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria
* HbA1c ≥ 7.0 and ≤ 9%
* Age ≥ 60 and ≤ 80

For the second objective (Longitudinal study):

* All patients recruited from the first objective are at moderate or high risk of falls according to the criteria of World Guidelines for Falls Prevention and Management for Older Adults - British Geriatric Society.

Exclusion Criteria:

* Acute diabetic complications
* Patients are in the acute phase of musculoskeletal disorders: acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis.
* Patients suffer from conditions significantly affecting cognition and mobility: sequelae of stroke (with weakness, limb paralysis), muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders.
* Patients have been bedridden due to illness for more than one month within the past three months up to the recruitment time.
* Patients with cardiovascular diseases: chest pain, uncontrolled blood pressure ≥160/100 mmHg, untreated cardiac arrhythmia, a history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy.

Primary outcomes:
measure: Physical performance 1 - Timed Up and Go (TUG)
timeFrame: Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)
measure: Physical performance 2 -Berg Balance Scale (BBS)
timeFrame: Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)
Secondary outcomes:
measure: Activities of Daily Living (ADLs)
timeFrame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
measure: Health-related Quality of Life
timeFrame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
measure: Functional Reach Test (FRT)
timeFrame: Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)
measure: Instrumental Activities of Daily Living (IADLs)
timeFrame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Geriatric Hospital
Study officials:
affiliation: National Geriatric Hospital
name: Huyen TT Vu, PhD
role: STUDY_CHAIR
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