Protocol summary
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Study aim
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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.
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Design
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A pragmatic community-based, randomized controlled trial with parallel groups
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Self-care; Health literacy; Social capital; Quality of life
General information
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Reason for update
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1-Realized sample size correction
2- Elimination of randomization from study design, and implementation of study with quasi-experimental method due to executive constraints and non-random allocation of two centers to intervention and control groups to prevent contamination of samples.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191011045056N1
Registration date:
2020-01-18, 1398/10/28
Registration timing:
retrospective
Last update:
2021-06-15, 1400/03/25
Update count:
1
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Registration date
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2020-01-18, 1398/10/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-23, 1398/08/01
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Expected recruitment end date
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2019-11-06, 1398/08/15
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Actual recruitment start date
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2019-10-23, 1398/08/01
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Actual recruitment end date
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2019-11-06, 1398/08/15
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Trial completion date
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2020-02-01, 1398/11/12
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Scientific title
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The effect of a complex multicomponent intervention on self-care, health literacy and social capital among older adults
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Public title
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Promoting self-care, health literacy and social capital in older adults
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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.
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Age
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From 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
Actual sample size reached:
86
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-07, 1397/12/16
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Ethics committee reference number
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IR.MUI.MED.REC.1397.311
Health conditions studied
1
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Description of health condition studied
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Elderly Quality of life
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ICD-10 code
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Z76.9
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ICD-10 code description
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Person encountering health services in unspecified circumstances
Primary outcomes
1
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Description
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Sُُelf-care
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Timepoint
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Self-care measurement at baseline (before intervention), immediately after, and 3 months after intervention
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Method of measurement
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Self-Care Questionnaire for the Elderly
2
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Description
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Health literacy
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Timepoint
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At baseline (before intervention), immediately, and 3 months after intervention
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Method of measurement
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Health Literacy for Iranian Adults (HELIA)
3
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Description
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Social Capital
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Timepoint
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At baseline (before intervention), immediately, and 3 months after intervention
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Method of measurement
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Onyx and Bullen Social Capital Questionnaire
Secondary outcomes
1
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Description
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Quality of life
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Timepoint
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At baseline (before intervention), immediately, and 3 months after intervention
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Method of measurement
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short form 12 quality-of-life questionnaire (SF-12)
Intervention groups
1
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Description
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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.
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Category
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Lifestyle
2
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Description
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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.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data in the study population can be shared with the exception of private features.
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When the data will become available and for how long
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The access period will start 6 months after the results are published.
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To whom data/document is available
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At the present stage it will be available to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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To the extent of analyzing data for academic researchers
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From where data/document is obtainable
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Department of Social and Family Medicine
N_motamedi@med.mui.ac.ir
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What processes are involved for a request to access data/document
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Submit a written request to the Director of Department of Social and Family Medicine
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Comments
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