| CTRI Number |
CTRI/2021/12/038791 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Use of a mobile-based application for fall education in older adults |
|
Scientific Title of Study
|
The impact of a mobile-based fall education application on fall risk factors in older adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room No: 305, Third floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202937305 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room No: 305, Third floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202937305 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room No: 305, Third floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202937305 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Health Research, Indian Council of Medical Research, V. Ramalingaswami Bhawan, P. O. Box No. 4911, Ansari Nagar, New Delhi, 1110029 |
| Manipal Academy of Higher Education, Manipal, Udupi, Karntaka, 576104 |
|
|
Primary Sponsor
|
| Name |
Sebestina Anita Dsouza |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi district, Karnataka 576104 |
| Type of Sponsor |
Other [Trust] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sebestina Anita Dsouza |
Kasturba Hospital |
Department of Occupational Therapy, 1st Floor, N1 Block, Kasturba Hospital
Udupi
KARNATAKA |
08202937305
sebestina.dsouza@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fall education |
The program is for three-months duration and involves six sessions. The first two sessions will be online in groups of 3-5 members and will cover the different components of fall education. These sessions would be for approximately 45 minutes. The third individual session will be in-person at their home. The pre-assessment findings will be discussed and tailored suggestions will be provided emphasizing on exercises, physical activity and removal of home hazards. They will also be provided the wearable device with instructions and demonstration on its use and the illustrated booklet on fall education. Following this, three reinforcement group sessions will be conducted online once a month. |
| Intervention |
Mobile-based fall education |
The program is for three-months duration and involves six sessions. The first two sessions will be online in groups of 3-5 members and will cover the different components of fall education. These sessions would be for approximately 45 minutes. The third individual session will be in-person at their home. The pre-assessment findings will be discussed and tailored suggestions will be provided emphasizing on exercises, physical activity and removal of home hazards. They will also be provided the wearable device and the mobile-based application with instructions and demonstration on its use. Following this, three reinforcement group sessions will be conducted online once a month. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Older adults aged 60 years and above
2. English or Kannada speaking
3. Able to use internet-enabled Android smartphones (only experimental group)
4. High school education
5. Able to answer everyday questions at a normal conversation level from 5 feet distance
6. Able to read a headline and a sentence in the newspaper with their regular glasses
7. Interested to take part in a fall prevention program
|
|
| ExclusionCriteria |
| Details |
Older adults with
1. Cognitive impairments (Mini-Mental Status Examination score of 24 and below)
2. High fall risk (based on World Fall guidelines (2022) this includes:
•2 or more falls in the past year
•inability to get up from the floor on falling
•injuries severe enough to consult physicians
•frailty (score of 4 or more on the Clinical Frailty Scale)
•loss of consciousness or suspected syncope
3. Self-reported severely disabling physical (medical, neurological, orthopedic) and psychiatric conditions
4. Self-reported pain that precludes them from participating in exercises and activities
5. Having health conditions for which mild-intensity exercises and activities are contraindicated.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed up and Go Test |
pre-test and after 3 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Exercise and Fall record |
3 months after pre-test |
| Fall-related knowledge, attitudes and practices |
pre-test, after 1 week of educational intervention and after 3 months |
| Falls Efficacy Scale International |
pre-test and after 3 months |
| Home-related Fall Risk Assessment |
pre-test and after 3 months |
| Timed up & Go test (Manual) |
pre-test & after 3 months |
| Timed up & go test (Cognitive) |
pre-test & after 3 months |
| 30 second Chair Stand Test |
pre-test & after 3 months |
| General Self-Efficacy scale. |
pre-test & after 3 months |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of the study is to develop a comprehensive and valid fall education program and a mobile-based application for older adults. The objectives are as follows: 1. To develop a fall education program 2. To develop a mobile-based fall education application 3. To determine the impact of the mobile-based fall education application on fall risk factors in older adults 4. To understand older adults’
perceptions and experiences of using wearables in a fall prevention program Justification for study (whether of national significance with rationale) : The ageing population in India is increasing exponentially (United Nations, 2013). The prevalence of falls is 14-53% (Dsouza et al., 2014) and is expected to increase with the increasing prevalence of non-communicable diseases. Falls affect older adults and their families, especially financially, affect independent living and increase dependency. Falls commonly occur at home and are potentially preventable (World Health Organization (WHO), 2007; 2018). Fall prevention is a critical component of health aging initiatives. Fall education is an essential component of fall prevention. Currently, it is provided at busy out-patient departments by health professionals with brief dyadic sessions mostly for those with health-related risk factors and occasionally through webinars for older adults in the community. These vary in content and delivery. We did not find much evidence of effective fall education programs in India. The adoption of fall prevention strategies continues to be low. The brief one-to-one sessions or general webinars attended by many may not be adequate for older adults to remember all the details. For better adoption, the fall education needs to be contextually relevant, accessible, personalized and reinforced several times. The use of mobile phones by older adults in India is steadily increasing, especially with the ongoing Covid pandemic. A mobile-based application or mhealth would make fall education more accessible to them, provide reinforcement, increase awareness, promote adoption of strategies, reduce or prevent falls, and there by support healthy ageing. The use of mhealth for fall education and prevention in older adults is underexplored in India. The present study intends to address this gap and would support health aging initiatives in India and the attainment of its SDG goals. Study description: The study will use a mixed-method approach and will involve three phases. In Phase I, the Fall education program and mobile-based application will be developed and tested. Phase II involves a quasi-experimental study with a two-arm cluster non-randomized controlled trial. Phase III involves a. focus group discussions with purposively selected participants of the experimental group/cluster for feedback regarding their experience with the mobile-based application and b. semi-structured interviews with purposively selected participants of both control and experimental groups to understand their experiences and perspectives on using wearables |