Determine the impact of lifestyle education based on pender model on frailty outcomes in community-dwelling older adults
Design
Clinical trial with control group, single-blind, randomized by 4-block method, 50 patients (25 people in each group).
Settings and conduct
The study population includes all the elderly referred to Omid Comprehensive Rehabilitation Clinic. Samples will be selected from those who meet the inclusion criteria. The calculated sample size is 50 people who will be randomly placed in the intervention and control group by the 4-block method. One-way blinding method will be used to prevent information bias.The present intervention will be performed for 3 months in 6 sessions of 30 minutes. The training will be done using a booklet based on the dimensions of a healthy lifestyle and through lectures, discussions and questions and answers. After the end of the training sessions until the end of the third month, telephone follow-up will be done on a weekly basis to follow up on the recommendations and fix the patients' problems. After the intervention, educational documents such as booklets and pamphlets will be provided to the control group.
Participants/Inclusion and exclusion criteria
inclusion criteria include:
Having a desire to participate in research; Having frailty syndrome based on the Tilberg scale; Not Having moderate or severe cognitive impairment; Not Participation in other interventions (physiotherapy, occupational therapy, intra-articular injections) in Omid Clinic or other centers. Exclusion criteria: Reluctance to continue the intervention; Having an acute or severe illness that makes it impossible to continue the intervention.
Intervention groups
Intervention group: Lifestyle education based on Pender model. Control group: without intervention.
Main outcome variables
Ability to perform activities of daily living; Hospital readmissions; Fear of falling; Limitations in physical function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049310N1
Registration date:2020-12-01, 1399/09/11
Registration timing:retrospective
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
milad moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 8440
Email address
mimoradi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-23, 1399/06/02
Expected recruitment end date
2020-11-30, 1399/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lifestyle education based on pender model on frailty outcomes in community-dwelling older adults
Public title
Effect of lifestyle education based on pender model on frailty outcomes in community-dwelling older adults
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A willingness to participate in research
Having frailty syndrome based on the Tilberg scale
Not Having Moderate or severe cognitive impairment
Do not participate in other interventions (physiotherapy, occupational therapy, intra-articular injections) in Omid Clinic or other centers
Exclusion criteria:
Having an acute or severe illness
Reluctance to participate in the intervention
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used to assign samples to each of the intervention and control groups; Initially, the size of the blocks was considered to be 4, according to the number of samples, 13 blocks were selected based on a table of random numbers and individuals were assigned to groups based on the position of the blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to prevent bias in the work results, one-way blinding will be used and data collection will be done by a trained nurse who has no knowledge of the intervention and control groups and the studied outcomes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery and Rehabilitation-Tehran University of Medical Sciences
Street address
Enghelab St, و Vesal Shirazi St, و Vesal Student Dormitory
City
Tehran
Province
Tehran
Postal code
1417743855
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.TUMS.FNM.REC.1399.080
Health conditions studied
1
Description of health condition studied
frailty syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Activities of Daily Living
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Katz Activities of Daily Living Inventory
2
Description
Fear of fall
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Falls Self-Efficacy Scale questionnaire
3
Description
Physical performance
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Short Physical Performance Battery Questionnaire & International Physical Activity Questionnaire
4
Description
Hospital readmissions
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Self-report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The present intervention will be performed for 3 months in 6 sessions of 30 minutes. The training will be done using a booklet based on the dimensions of a healthy lifestyle and through lectures, discussions and questions and answers. After the end of the training sessions until the end of the third month, telephone follow-up will be done on a weekly basis to follow up on the recommendations and fix the patients' problems.
Category
Other
2
Description
Control group: After the intervention, educational documents such as booklets and pamphlets will be provided to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Rehabilitation Clinic
Full name of responsible person
Neda Omid
Street address
South to North Valiasr St., Motahhari Intersection, Hosseini Rad Alley, No. 34
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 21 8880 1800
Email
miladmoradi3843@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?