Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over
SAFRAPP
The Effect of Salutogenic Model Based Frailty Prevention Program on Development of Frailty and Sense of Coherence in Women Aged 55 Years and Over
1 other identifier
interventional
84
0 countries
N/A
Brief Summary
Frailty is a condition of reduced the capacity in multiple body systems and causing adverse outcomes because of decreasing the ability to cope with stressors. Female sex, the changes of the body imposed by ageing, and coping strategies for stressors are causal mechanisms in the development of frailty. This project is designed with the salutogenic model that is focused on the concepts of health, stress, and coping. The aim of this project is to assess the effect of Salutogenic Frailty Prevention Program on promoting sense of coherence and preventing the development of frailty in women aged 55 years and over
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedMarch 8, 2021
March 1, 2021
6 months
March 2, 2021
March 5, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Sense of Coherence
Sense of coherence assesses an individual's orientation and internal strengths. It consists of 13 items rated on a 7-point Likert scale, and has three components including comprehensibility (5-item), manageability (4-item) and meaningfulness (4-item)
Baseline, 3 months, 6 months, 9 months
Change in FRAIL scale
The FRAIL scale consists of 5 items (fatigue, resistance, ambulation, illnesses, loss of weight). Frail scale scores range from 0-5 and represent frailty status as frail (3-5), pre-frail (1-2), and robust (0).
Baseline, 3 months, 6 months, 9 months
Secondary Outcomes (6)
Change in The World Health Organisation- Five Well-Being Index (WHO-5)
Baseline, 3 months, 6 months, 9 months
Change in health-related quality of life
Baseline, 3 months, 6 months, 9 months
Change in EQ-VAS
Baseline, 3 months, 6 months, 9 months
Change in number of falls
Baseline, 3 months, 6 months, 9 months
Change in fear of fall
Baseline, 3 months, 6 months, 9 months
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALExperimental: SAFRAPP Intervention Participants in this group will receive a 6-week SAFRAPP intervention, comprising of laughter yoga, health education and case management. SAFRAPP will be conducted on social media (Facebook and WhatsApp).
Control Grup
NO INTERVENTIONThe control group will not receive any intervention during the study. Participants in the control group will take the same program after the study is completed.
Interventions
Laughter yoga: The first component of intervention is the laughter yoga that is a combination of warm up exercise, deep breathing exercises, childlike playfulness and laughter exercises. Each session of laughter yoga will be offered twice a weekly and 40 minutes each time. Health education: The second component of intervention consisted of six health issues which are "health, frailty and generalized sources of resistance for frailty", the most common medical condition and medication use", "physical activity", "healthy diet", "falls prevention" and "cognitive and psychosocial well-being". Case management: The third component of intervention is activities that determine each participant's health needs with the Omaha System and support them for the use of appropriate resources.
Eligibility Criteria
You may qualify if:
- Willing to participate in the study
- Woman aged 55 years and over
- Pre-frail (Total FRAIL scale score 1 or 2)
- Has Internet access
You may not qualify if:
- To be semi-dependent and dependent according to the Katz Daily Activities Activity Scale
- To have any cognitive, psychiatric and neurological disorders
- To have any surgical operation in the past 3 month
- Communication barrier (due to hearing/vision impairment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Yas MA, Secginli S. Salutogenic Model-Based Frailty Prevention Program for Pre-Frail Women Aged 55 Years and Over (SAFRAPP): A Study Protocol for a Randomized Controlled Trial. Res Theory Nurs Pract. 2022 Apr 1;36(2):215-232. doi: 10.1891/RTNP-2021-0098.
PMID: 35584890DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 8, 2021
Study Start
March 1, 2021
Primary Completion
September 1, 2021
Study Completion
January 1, 2022
Last Updated
March 8, 2021
Record last verified: 2021-03