The purpose of this study is to evaluate the effect of a complex multicomponent intervention on self-care, health literacy, and social capital among older adults compared to the usual care of older adults in health care centers.
Design
A pragmatic community-based, randomized controlled trial with parallel groups, simple randomization
Settings and conduct
The effectt of the intervention on self-care, health literacy, social capital, and quality of life will be assessed before and immediately after and three months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age 60 year or above.
minimum literacy skills.
Exclusion criteria:
need help to go to the primary health care centres.
cognitive impairment or dementia.
medical conditions that contraindicates physical activity.
any severe mental health problem that hinders participation in a group participation.
Intervention groups
Intervention group:
Educational intervention program for two groups of 20 elderly people is conducted in two urban health sites in intervention groups.
The intervention program consists of twelve weekly and two-hour training sessions and local trips. Nine group training sessions at the health center with topics such as health and self-care, physical activity, emotional health, healthy eating habits, loneliness and social interaction, community participation, personal autonomy, communication with health professionals, and group discussion . Three more meetings : local trip , a park (or physical activity area), a large store, and a regional volunteer community center. The intervention team consists of four health care providers and one physician who take a two day workshop.
control group:The two control groups continue to receive routine elderly care.
Main outcome variables
Self-care; Health literacy; Social capital; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191011045056N1
Registration date:2020-01-18, 1398/10/28
Registration timing:retrospective
Last update:2020-01-18, 1398/10/28
Update count:1
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Narges Motamedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8145
Email address
n_motamedi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a complex multicomponent intervention on self-care, health literacy and social capital among older adults
Public title
Promoting self-care, health literacy and social capital in older adults
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
They are community-dwelling aged 60 year or above.
They have minimum literacy skills.
Exclusion criteria:
They need help to go to the primary health care centres (PCC).
They have cognitive impairment or dementia.
They have a medical condition that contraindicates physical activity.
They have any severe mental health problem that hinders participation in a group participation.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A sample size of 80 older adults who are included in the study are randomly assigned to two groups of intervention and control. SPSS 22 software is used for random allocation, so that the Data View contains eighty codes from one to 80 as case; Then, by selecting Random sample of cases option from the Data menu, half of the cases are randomly assigned zero code, and the other half one code. One codes are assigned to the intervention group and zero codes to the control group.
The intervention group will then be contacted to participate in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar grib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-07, 1397/12/16
Ethics committee reference number
IR.MUI.MED.REC.1397.311
Health conditions studied
1
Description of health condition studied
Elderly Quality of life
ICD-10 code
Z76.9
ICD-10 code description
Person encountering health services in unspecified circumstances
Primary outcomes
1
Description
Sُُelf-care
Timepoint
Self-care measurement at baseline (before intervention), immediately after, and 3 months after intervention
Method of measurement
Self-Care Questionnaire for the Elderly
2
Description
Health literacy
Timepoint
At baseline (before intervention), immediately, and 3 months after intervention
Method of measurement
Health Literacy for Iranian Adults (HELIA)
3
Description
Social Capital
Timepoint
At baseline (before intervention), immediately, and 3 months after intervention
Method of measurement
Onyx and Bullen Social Capital Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
At baseline (before intervention), immediately, and 3 months after intervention
Method of measurement
short form 12 quality-of-life questionnaire (SF-12)
Intervention groups
1
Description
Intervention group: This study is a community-based study with multiple and varied components implemented in a multifaceted intervention program. Intervention and content of the sessions are based on a similar study protocol that was previously published in BMC Public Health (2018). the intervention is described with the TIDieR Guidelines below. It is designed to enhance social support and participation (social capital), Self-care, and health literacy in the elderly as mediating factors between social determinants and health outcomes, and with the potential to improve the quality of life and well-being of the elderly. Intervention materials and methods have been slightly adjusted to fit our country's cultural and indigenous conditions. The intervention program consists of 12 weekly and two-hour sessions with the following topics: Sessions (contents, materials and procedures) 1. Health and Self Care: Introducing the Program, Participants introduce themselves , group discussion using photos of self-care daily activities, asking the group to bring a personal item from home the next meeting, creating a wall newspaper of member paintings, handicrafts, writing and ... 2. Physical Activity: Participants talk about the personal object they brought from home, discussing and setting a specific goal of daily living achievable during the week. Identifying appropriate locations for physical activity using local mapping, short instruction and discussing about the benefits and limitations of physical activity, agreeing on the destination for a group walk in the next session 3. Local First Walk: Group does a Walk with Origins Start and end at the health center and do physical activity in a place like a park or gym 4. Emotional health: Talk about achieving personal goals. Short tutorials on problem-solving techniques, group discussion on coping strategies, a relaxation exercise 5. Healthy eating habits: short tutorials on healthy and inexpensive eating tips, group discussion on eating habits, and nutrition tips Cheaper and and about the places where they shop. Agree on the market or store for local circulation next week 6. Second local circulation: Groups visit the local supermarket. During the meeting they discuss their eating habits and preferences for shopping. 7. Loneliness and Social relationships: A brief tutorial on concepts of loneliness and social relationships, group discussion focusing on thoughts and perceptions of loneliness and social relationships. Divide the group into subgroups to create keywords stories about social communication. 8. Community Participation: Reading a story about a woman participating in local community activities by a member aloud, identifying important local community activities using the local map and discussing them, group discussion on the limitations and benefits of social participation, Agree on an important social place in the area for the next visit 9. Third Local Circle: The group visits an important local place, one of the site's operators explains to the group about the place and its activities. Groups are encouraged to participate in social activities.10. Personal autonomy: A brief tutorial on the concept of personal autonomy, group discussion on personal autonomy, discussion of the practical case put forward by the trainer. 11. Get in touch with health professionals: A video showing how to prepare for a medical encounter. Describe the thoughts and feelings of the group members when meeting a health care provider and their personal knowledge of health resources in the community 12. Group Discussion Final Session: Expressing People's Thoughts and Feelings about the Program, Creating, and Donating an Imaginary Gift to Another Participant , The group shares a farewell meal. The intervention team consists of four health care providers and one physician (with experience in health care) will be previously trained as group facilitators by the research team during a two-day workshop based on the instructional guide. Intervention is carried out at two urban health sites including 12 weekly and two hour sessions and is conducted for two groups of 20. Each participant receives a code and completes the questionnaires at the beginning of the study by interviewing them. Outcome interviewers are selected from health care providers who are not involved in the intervention. They receive the necessary training on interviewing and filling out questionnaires before they start. One or two health care providers as observers record quantitative and qualitative measures of implementation such as fidelity and adherence.
Category
Lifestyle
2
Description
Control group: the participants from control group will receive the usual universal healthcare services available in health centers. At the end of the program, they are suggested to enter the intervention group in the next period of program implementation.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
district Health Center of Isfahan
Full name of responsible person
Narges Motamedi
Street address
Feiz street
City
Isfahan
Province
Isfehan
Postal code
8164969459
Phone
+98 31 3661 7702
Email
n_motamedi@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Ebnesina urban Health Center
Full name of responsible person
Narges Motamedi
Street address
Ebnesina urban Health Center, EbneSina Street
City
Isfahan
Province
Isfehan
Postal code
8148665923
Phone
+98 31 3445 9039
Email
dean@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjooye Javanmard
Street address
Hezar Jarib Street-Vice Chancellery of Research and Technology
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8139
Email
N_motamedi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Motamedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
School of Medicine, Isfahan University Of Medical Sciences, Hezar Jerib street
City
Esfahan
Province
Isfehan
Postal code
7346181764
Phone
+98 31 3792 8145
Fax
Email
N_motamedi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Motamedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
School of Medicine, Isfahan University Of Medical Sciences, Hezar Jerib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8145
Fax
Email
N_motamedi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Taherian
Position
Community Medicine Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Public Health/Community Medicine
Street address
School of Medicine, Isfahan University Of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3660 5014
Email
Drztaheriyan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data in the study population can be shared with the exception of private features.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
At the present stage it will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To the extent of analyzing data for academic researchers
From where data/document is obtainable
Department of Social and Family Medicine
N_motamedi@med.mui.ac.ir
What processes are involved for a request to access data/document
Submit a written request to the Director of Department of Social and Family Medicine