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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
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    March 2, 2021
    Last Updated
    March 5, 2021
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    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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