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Designing Occupation-Centered Self-management interventions and investigating its effect on Performance, Satisfaction and self- efficacy of people diagnosed with type 2 diabetes

Protocol summary

Study aim
Designing and evaluating occupation-centered self-management interventions in people with type 2 diabetes
Design
A randomized clinical trial with control group, single blind(assessor blind)
Settings and conduct
The place of the study is the school of rehabilitation of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged 30 to 60 years with a diagnosis of type 2 diabetes for at least one year with no co morbidity, being literate, being in occupational imbalance, interested in engagement in related activities and the ability to use cell phone or short message system Exclusion criteria: Unwillingness to continue working with the research team, injury or severe illness, no referral for gathering blood samples, two sessions of continuous absence or four absentee sessions throughout the treatment sessions
Intervention groups
The occupation-centered self management intervention will be implemented in the intervention group. Details of this intervention will be determined during expert panel meetings and a preliminary study. Various ways such as education, counseling, coaching, feedback and discussion among the members of the group will be used to facilitate the performance of the participants in different areas of self-management. Initially, nine sessions of intervention, once a week, are scheduled for 60 minutes per session. In order to generalize the skills to real life, the logbook is available to each participant and homework assignments are set for individuals. In the control group, participants will receive a booklet. The content of the program and its importance will explained to them by research team members. Also, follow up is done by telephone calls.
Main outcome variables
Performance, Satisfaction, Self Efficacy, Fasting Blood Sugar, A1c, Lipid profile, Creatinine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180105038224N1
Registration date: 2018-12-02, 1397/09/11
Registration timing: prospective

Last update: 2018-12-02, 1397/09/11
Update count: 0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Maryam Binesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7159
Email address
Binesh.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing Occupation-Centered Self-management interventions and investigating its effect on Performance, Satisfaction and self- efficacy of people diagnosed with type 2 diabetes
Public title
Designing Occupation-Centered Self-management interventions and investigating its effect on Performance, Satisfaction and self- efficacy of people diagnosed with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 2 diabetes for at least 1 year No co-morbidity based on patient's report and doctor's diagnosis Age range of 30 to 60 years Being literate Occupational balance score of less than 2.5 according to Life Balance Inventory Interested in participating in study-related activities Ability to use cellphone or short message system
Exclusion criteria:
Unwillingness to continue working with the research team Severe injury or illness during the implementation of the program No referral for gathering blood sample Two consecutive absence or four absentee sessions throughout the treatment sessions
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation is done using random cards
Blinding (investigator's opinion)
Single blinded
Blinding description
All assessments in both groups will be done by an unaware examiner of the random allocation method. All assessments will be done 3 times: before the first intervention session, after the end of the intervention and three months thereafter
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.IUMS.REC1396.9321525002

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E10-E14
ICD-10 code description
E11.8 Type 2 diabetes mellitus with unspecified complications

Primary outcomes

1

Description
Satisfaction
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
The Canadian Occupational Performance Measure

Secondary outcomes

1

Description
Performance
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
The Canadian Occupational Performance Measure

2

Description
Self Efficacy
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
The diabetes empowerment scale

3

Description
Fasting Blood Sugar
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
Blood samples

4

Description
Hemoglobin A1c
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
Blood samples

5

Description
Lipid Profile
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
Blood samples

6

Description
Creatinine
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
Blood samples

7

Description
Distress
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
The diabetes distress scale

8

Description
Self care
Timepoint
Before the intervention, after the end of the intervention, 3 months later
Method of measurement
The summary of diabetes self care activities measure

Intervention groups

1

Description
Intervention group: Occupation- centered self-management intervention will be conducted in the intervention group. Intervention sessions will be hold using various methods such as education, counseling, coaching, feedback, and discussion among members by group format to facilitate performance in different areas of self-management. At intervals between sessions, the therapist will check the attendance rate through a phone call or SMS. Also, participants can ask their questions one day of per week in person or by phone. In order to generalize the skills to real life, the logbook is available to each participant and homework assignments are set for individuals. At the beginning of the meetings, people will talk about the experience of generalizing their real life skills. Details and schedules of the various intervention sessions will be determined after the expert panel sessions and a preliminary study. Initially, nine sessions of intervention, once a week, are scheduled for 60 minutes per session
Category
Rehabilitation

2

Description
Control group: The control group will receive the current self-management program implemented through the existing educational booklet at Endocrinology and Metabolism Research Center of Iran University of Medical Sciences. The booklet will be explained to the participants in a 15-minute session. Also, the rate of tracking the program by individuals and answering their questions will be done by the research team using telephone at regular intervals.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center affiliated to Iran University of Medical Science
Full name of responsible person
Maryam Binesh
Street address
Endocrinology and Metabolism Institute of Iran University of Medical Sciences, Firoozeh Alley, Valiasr avenu
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Email
maryami.binesh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansooreh Hossein Mardi
Street address
Iran University of Medical Sciences, Hemat Highway next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2543
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
30
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
Iran University of Medical Sciences
Full name of responsible person
Afsoon Hassani Mehraban
Position
عضو هیئت علمی
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Mother's Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
afsoonmehraban@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsoon Hassani Mehraban
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Shah Nazari St, Mother's Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
afsoonmehraban@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Binesh
Position
دانشجوی دکترای تخصصی
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
maryami.binesh@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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