Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345118
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-18
Brief Title:
Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Sponsor:
National Geriatric Hospital
Organization:
National Geriatric Hospital
Study Overview
Official Title:
Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FallT2DMOLD
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
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 399 million people with diabetes aged 20-79 in 2021 in Vietnam and this population will reach 601 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 28 million injuries treated in emergency departments annually including over 800000 hospitalizations and over 27000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None