Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over (SAFRAPP)
Primary Purpose
Frailty, Frailty Syndrome, Salutogenesis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Salutogenic Frailty Prevention Program
Sponsored by
About this trial
This is an interventional prevention trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- Willing to participate in the study
- Woman aged 55 years and over
- Pre-frail (Total FRAIL scale score 1 or 2)
- Has Internet access
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control Grup
Arm Description
Experimental: 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).
The 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.
Outcomes
Primary Outcome Measures
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)
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).
Secondary Outcome Measures
Change in The World Health Organisation- Five Well-Being Index (WHO-5)
The five-items Well-Being Index will be used to assess participants' psychological well-being.
Change in health-related quality of life
The EQ-5D-3L descriptive system evaluates the participants' health state in the five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Change in EQ-VAS
EQ visual analogue scale (EQ-VAS) is a vertical scale that assesses the participant's own judgement regarding their health between 0 and 100.
Change in number of falls
Participants will be asked about the number of falls in the past three months
Change in fear of fall
Participants will be asked a single question: Are you afraid of falling? The possible answers were never afraid," sometimes afraid," afraid, and always afraid.
Change in number of emergency admissions
Participants will be asked about the number of the emergency visit in the past 3 months
Full Information
NCT ID
NCT04787432
First Posted
March 2, 2021
Last Updated
March 5, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04787432
Brief Title
Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over
Acronym
SAFRAPP
Official Title
The Effect of Salutogenic Model Based Frailty Prevention Program on Development of Frailty and Sense of Coherence in Women Aged 55 Years and Over
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Frailty Syndrome, Salutogenesis, Sense of Coherence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Experimental: 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).
Arm Title
Control Grup
Arm Type
No Intervention
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Salutogenic Frailty Prevention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sense of Coherence
Description
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)
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in FRAIL scale
Description
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).
Time Frame
Baseline, 3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
Change in The World Health Organisation- Five Well-Being Index (WHO-5)
Description
The five-items Well-Being Index will be used to assess participants' psychological well-being.
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in health-related quality of life
Description
The EQ-5D-3L descriptive system evaluates the participants' health state in the five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in EQ-VAS
Description
EQ visual analogue scale (EQ-VAS) is a vertical scale that assesses the participant's own judgement regarding their health between 0 and 100.
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in number of falls
Description
Participants will be asked about the number of falls in the past three months
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in fear of fall
Description
Participants will be asked a single question: Are you afraid of falling? The possible answers were never afraid," sometimes afraid," afraid, and always afraid.
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in number of emergency admissions
Description
Participants will be asked about the number of the emergency visit in the past 3 months
Time Frame
Baseline, 3 months, 6 months, 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willing to participate in the study
Woman aged 55 years and over
Pre-frail (Total FRAIL scale score 1 or 2)
Has Internet access
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve ALTINER YAS, MSc
Phone
+90 (212) 404 03 00
Ext
27042
Email
altinermerve90@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Selda SECGINLI, PhD
Email
secginli@istanbul.edu.tr
12. IPD Sharing Statement
Citations:
PubMed Identifier
35584890
Citation
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.
Results Reference
derived
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Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over
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