1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of diabetic rehabilitation on happiness and resilience of type 2 diabetic patients and their family caregivers, referring to diabetes clinics affiliated to Shiraz Medical Science University, in 1998-99

Protocol summary

Study aim
Diabetic rehabilitation effect on type 2 diabetic patients and their family caregivers
Design
A random clinical trial with two groups of intervention and control, based on the story of the central limit in statistics, sample size in the control and intervention groups of 70 and including a 10% drop in Each group consists of 39 people, The samples will be selected first using the available sampling method using a table of random numbers and according to the entry criteria, and then and by completing the questionnaires, random allocation with block randomization list with size 4 blocks of 17 and 2 blocks of 5, a total of 6 blocks, will be in the two groups of control and intervention
Settings and conduct
Shiraz Medical Sciences University-affiliated Clinics, The intervention group will receive diabetic rehabilitation during 8 session of face-to-face visits and 8 phone calls between face -to-face sessions; The control group will receive routine clinical care, training on diet and medication
Participants/Inclusion and exclusion criteria
Inclusion criteria, Diagnosis of diabetes by a specialist, literacy, Patients and their family caregivers willingness and satisfaction with to participate in the study, Physical ability to travel to the clinic; Exclusion criteria, Failure to attend the training session for two consecutive sessions, Mental retardation and mental disorders, Unpleasant events for the samples during the study, The incidence of sickness in the samples
Intervention groups
Intervention Group will receive the Diabetes Rehabilitation Program including diabetes introduction and its complications, treatment and self-control of blood sugar, foot care, nutrition, exercise, happiness and resilience training and self-management; control group will receive routine clinical care, diet and medication
Main outcome variables
Happiness and Resilience Score with OHQ and CD-RISC scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200313046758N1
Registration date: 2020-06-28, 1399/04/08
Registration timing: registered_while_recruiting

Last update: 2020-06-28, 1399/04/08
Update count: 0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Sepide Sheikh Hasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 8562
Email address
sepideshh112233@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of diabetic rehabilitation on happiness and resilience of type 2 diabetic patients and their family caregivers, referring to diabetes clinics affiliated to Shiraz Medical Science University, in 1998-99
Public title
Diabetic rehabilitation effect on type 2 diabetic patients and their family caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetes by a specialist literacy Patients and their family caregivers willingness and satisfaction with to participate in the study Physical ability to travel to the clinic
Exclusion criteria:
Failure to attend the training session for two consecutive sessions Mental retardation and mental disorders Unpleasant events for the samples during the study (such as losses and calamities that can aggravate distress or prevent participation in the intervention and continue cooperation in the study) The incidence of sickness in the samples that causes them to be hospitalized and prevents them from participating in the intervention and continuing to work with the researcher
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 156
More than 1 sample in each individual
Number of samples in each individual: 2
Since no similar study was found on these patients, which was consistent with the present study objectives, according to the central limit theorem in statistics, the sample size in each group was 35, minimum sample for normal data distribution and Parametric statistical tests usage, and a total of 70 people, including family caregivers, 140 people are considered, and after collecting data and obtaining results by analyzing the power, the power of this sample volume in showing significant differences is calculated and Reported. Taking into account the 10% drop in sample size in each group, 39 people were obtained; 78 people in the intervention group, 39 patients plus 39 family caregivers, and 78 people in the control group, 39 patients plus 39 family caregivers, a total of 156 participants will become participants.
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are first selected using the available sampling method using a random number table and according to the input criteria, then complete the questionnaires and random allocation using Random allocation software to generate a block randomization list, With the size of 4 blocks of 17 and 2 blocks of 5, a total of 6 blocks will be in two groups of intervention and control, which will be a total of 78 people, 39 people in the intervention group and 39 people in the control group, It should be noted that since the present study will be performed on the patient and his family caregiver, the patient's family caregiver will also be subject to intervention, taking into account the intervention group of 78 people, 39 patients plus 39 family caregivers, and the control group 78 A total of 156 people, 39 patients plus 39 family caregivers, will be included.
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that the questionnaires are distributed at all stages by the researcher and also the data analyzer will be unaware of the random allocation of groups to the intervention and control group, then the outcome assessor and data analyzer from the intervention and control groups they will not be aware.
Placebo
Not used
Assignment
Parallel
Other design features
The present study will be performed on type 2 diabetic patients and their family caregivers, Taking into account the drop of 10%, 39 patients and 39 family caregivers will be included in a total of 78 people in each of the intervention and control groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fatemeh Nursing and Midwifery Faculty, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7936-13119
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.SUMS.REC.1398.1330

Health conditions studied

1

Description of health condition studied
Type 2 diabetic patients
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

2

Description of health condition studied
Family caregivers of type 2 diabetic patients
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Happiness score
Timepoint
First time, before beginning the intervention, second time, at the end of the 8th session, third time, 5 weeks after the second time
Method of measurement
Oxford Happiness Questionnaire

2

Description
Resiliency score
Timepoint
First time, before beginning the intervention, second time, at the end of the 8th session, third time, 5 weeks after the second time
Method of measurement
Conner and Davidson Resiliency scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group, during 8 weeks and 8 face-to-face sessions will receive the rehabilitation program for diabetes, including introduction of diabetes education, treatment and its complications, foot care and self-control of blood sugar, nutrition and diet, exercise and amount of daily activity Individual, happiness training that includes, motivation and purpose, communicating with others and receiving support from them, being active, achieving, feeling positive and resilience training that includes, gaining self-awareness skills, positive thinking and optimism, problem-solving skills and anger management, crisis management and coping strategies, and the eighth session of diabetes management itself, which includes a summary of what has been said in previous sessions; And 8 times by phone, every 8 weeks after each training session Present and before the next meeting, based on the rehabilitation program and with the objectives of teaching, and if necessary, re-teaching the topics discussed in the face-to-face meetings, removing ambiguities and answering sample questions and remembering the time and place of the meeting The future will be and at the end of each session, educational pamphlets will be distributed
Category
Rehabilitation

2

Description
Control group, will receive no intervention and will only receive the clinical care routine, training on diet and medication
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dr. Faghihi Specialty and Specialty Hospital
Full name of responsible person
Sepideh Sheikh Hasani
Street address
Next to School of Medicine, Karim Khan Zand Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۴۱۱۹
Phone
+98 71 3235 1087
Fax
Email
faghihihsp@sums.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Motahari Specialty and Specialty Clinic
Full name of responsible person
Sepideh Sheikh Hasani
Street address
Shahid Motahari Specialized and Specialized Clinic, Next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
717437-71348
Phone
+98 71 3612 1000
Fax
+98 71 3647 4673
Email
motahari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Qasemi
Street address
Headquarters of Shiraz University of Medical Sciences, opposite Palestine Street, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Rakhshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh Nursing and Midwifery Faculty, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
0098 7136474254-8
Email
rakhshanm@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Rakhshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh Nursing and Midwifery Faculty, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
0098 7136474254-8
Email
rakhshanm@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sepideh Sheikh Hasani
Position
Ms.c Student of Medical-Surgical Nursing Education
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fatemeh School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 23 3222 8562
Email
sepideshh112233@gmail.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
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Obtaining a license to implement the project from the School of Midwifery Nursing officials, Obtaining a license from the research environment officials, Provide basic and necessary information about research goals to all study people, Collecting data, Educate and provide a summary of training to the control group, The confidentiality of the collected information
When the data will become available and for how long
After completing the study and publishing the results
To whom data/document is available
Private and public centers and Educational centers, where the researcher has taken samples
Under which criteria data/document could be used
Obtaining permission from the faculty and center officials where the sampling was performed and keeping the information confidential
From where data/document is obtainable
Mr. Qasemi Library, Shiraz School of Nursing and Midwifery Library, Zand Street, Shiraz, phone: 00987136474254
What processes are involved for a request to access data/document
Requests for the results will be sent to the Shiraz School of Nursing and Midwifery library, They will be provided with the arrangements made
Comments
Loading...