Protocol summary
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Study aim
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To study the effect of integrate peer - nurse education on diabetes quality of life and self-care in old-age patients with type 2 diabetes
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Design
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Two arm parallel group randomized trial with blinded postoperative care
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Settings and conduct
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After goal-based sampling method, reviewing the records of diabetic patients at the Yazd diabetes research center, patients are recruited for inclusion in the study with type II diabetes. Then by random selection with Random Allocation software, It is explained in terms of research objectives and they are told that they may be in the control group or test then patients divide randomly into two intervention and control groups (each of the groups 40 people).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: consent for participate in the study; patients with established diabetes type II for at least 6 month; able to be in direct or indirect communication with patients; age between 60-70 years old; ability to speak Persian.
Exclusion criteria: patients with cognitive disorders; taking anti depression drugs(with or without a prescription); patients without participation in two educational sessions; patients without consent to continue in the study; death of the patients during the study.
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Intervention groups
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Samples were assigned into 2 groups of 40 subjects, control group and intervention group, the participants in the intervention group will educate by collaborative peer-nurse education for 6 following months (10 sessions of 2 H) they will receive these subjects: defined in relation to the identification diabetes, complications, the role of diet, physical activity, foot care, self-monitoring medications to control diabetes while Control group only received usual care including periodical physician visits and diabetic regular educational classes.
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Main outcome variables
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Diabetes Quality Of Life; Diabetes Self-care Activities
General information
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Reason for update
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modification the study process
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170815035709N2
Registration date:
2018-09-20, 1397/06/29
Registration timing:
prospective
Last update:
2020-10-21, 1399/07/30
Update count:
1
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Registration date
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2018-09-20, 1397/06/29
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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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2018-10-07, 1397/07/15
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Expected recruitment end date
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2019-01-05, 1397/10/15
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Actual recruitment start date
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2018-10-07, 1397/07/15
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Actual recruitment end date
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2019-01-05, 1397/10/15
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Trial completion date
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2019-06-05, 1398/03/15
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Scientific title
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The effect of integrate peer - nurse education on diabetes quality of life and self-care in old-age patients with type 2 diabetes
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Public title
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The effect of education on diabetes quality of life and self-care in diabetic old-age patients
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Consent for participate in the study
Patients with established diabetes type II for at least 6 month
Able to be in direct or indirect communication with patients
Age between 60-70 years old
Ability to speak Persian
Exclusion criteria:
Patients with cognitive disorders
Physical disability
Taking anti depression drugs (with or without a prescription)
Patients without participation in two educational sessions
Patients without participation in the study
Death of patients during the study
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Age
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From 60 years old to 70 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:
73
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After goal-based sampling method, reviewing the records of diabetic patients at the clinic we select patients are eligible for inclusion in the study with type II diabetes. Then by random selection with Random Allocation software, It is explained in terms of research objectives and they are told that they may be in the control group or test then patients divide randomly into two intervention and control groups (each of the groups 40 people)
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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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2017-06-20, 1396/03/30
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Ethics committee reference number
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IR.SSU.REC.1396.79
Health conditions studied
1
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Description of health condition studied
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Diabetes mellitus
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ICD-10 code
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E10-E14
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ICD-10 code description
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Diabetes mellitus
Primary outcomes
1
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Description
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Diabetes Quality Of Life
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Timepoint
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Before the intervention; after intervention and six months after the intervention
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Method of measurement
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DQOL (Diabetes Quality Of Life), SDSCA (Summary of Diabetes Self-care Activities)
2
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Description
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Diabetes Self-care Activities
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Timepoint
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Before the intervention; after intervention and six months after the intervention
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Method of measurement
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Summary of Diabetes Self-care Activities(SDSCA)
Secondary outcomes
1
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Description
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Glycosylated hemoglobin
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Timepoint
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Before the intervention, six months after the intervention
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Method of measurement
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Percentage
2
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Description
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Weight control
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Timepoint
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Before the intervention, six months after the intervention
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Method of measurement
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Kilogram
3
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Description
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Abdominal circumference
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Timepoint
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Before the intervention, six months after the intervention
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Method of measurement
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Centimeter
Intervention groups
1
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Description
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Intervention group: after preparing peers, the participants in the intervention group will educate by collaborative peer-nurse education for 6 following months (10 sessions of 2 hours) 6 sessions constantly receive these subjects: defined in relation to the identification diabetes, complications, the role of diet, physical activity, foot care, self-monitoring medications to control diabetes. In the end of each session, they asking and answering and sharing their personal experiences and success on the diabetes disease control. In the end of the period, intervention group receive the diabetes self-management booklet
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Category
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Lifestyle
2
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Description
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Control group: control group only received usual care including periodical physician visits and diabetic regular educational classes
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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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Yazd 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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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable