Determining the effect of the home visiting program on caregiving pressure and self-efficacy of caregivers of veterans with diabetes
Design
A single-blind randomized controlled clinical trial in which the randomization method is used by lottery from the list of samples
Settings and conduct
In the home of eligible veterans, entry into the study will take place in the presence of the main caregiver and with informed consent in Gorgan city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: caring for a veteran with 50% or more diabetes; complete and full-time care of the veteran; caregiver's absence of disease at the time of research; having at least the fifth primary level of care; not caring for another patient at the same time as caring for a veteran; not having stressful experiences in the past six months. Exclusion criteria: unwillingness to cooperate and continue studying; death of study caregiver or veteran; caregiver suffering from an acute illness or hospitalization while conducting research. A veteran suffering from an acute illness or being hospitalized while conducting research; the occurrence of a stressful event for the caregiver during the research; cancellation of 2 consecutive visit sessions.
Intervention groups
Trainings based on meeting care needs and according to people's abilities
Main outcome variables
care pressure; self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231018059763N1
Registration date:2024-01-19, 1402/10/29
Registration timing:registered_while_recruiting
Last update:2024-01-19, 1402/10/29
Update count:0
Registration date
2024-01-19, 1402/10/29
Registrant information
Name
Mohammad Maghsoudloomahali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3236 4770
Email address
mohammadmaghsoudloo5784@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of the home visit program on the burden of care and self-efficacy of the Caregivers of veterans with diabetes
Public title
Investigating the effect of home visits on caregiving pressure and self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Caring for a veteran with 50% or more of diabetes
Providing full and full-time care for the veteran
Not having a disease at the time of the research
Having at least fifth grade education
Not caring for another patient at the same time as caring for the veteran
Not having stressful experiences during The past six months
Exclusion criteria:
Unwillingness to cooperate and continue studying
Death of the study caregiver or veteran
Caregiver suffering from an acute illness or hospitalization while conducting research
A veteran suffering from an acute illness or being hospitalized while conducting research
The occurrence of a stressful incident for the caregiver during the research
Cancellation of 2 consecutive visit sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. First a list of eligible study entry samples that have submitted their consent by filling out the informed consent form is drawn then the first sample is placed in the intervention group and the next sample is placed in the control group and this continues until all the samples are completed and at the end we will have an equal group
Blinding (investigator's opinion)
Single blinded
Blinding description
The samples in each group are unaware of the existence of the other group
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zabol University of Medical Sciences
Street address
Shahid bagheri Ave., Rajaei Ave.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
IR.ZBMU.REC.1402.080
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E10-E14
ICD-10 code description
Incl.: diabetes (mellitus)(nonobese)(obese): • adult-onset • maturity-onset • nonketotic • stable non-insulin-dependent diabetes of the young Excl.: diabetes mellitus (in): • malnutrition-related (E12.-) • neonatal (P70.2) • pregnancy, childbirth and the
Primary outcomes
1
Description
"Care pressure score in the Novak and Ghost questionnaire ""automatic rate in the Scherer and colleagues questionnaire"
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Care pressure of Novak and Gost questionnaire and self-efficacy questionnaire of Sherer et al
Secondary outcomes
empty
Intervention groups
1
Description
The intervention consists of 4 home visits which address the needs of care and their education on diabetes the duration of each session is 40 minutes and each session addresses specific topics in the context of the situations that a person needs in relation to diabetes
Category
Behavior
2
Description
Control group: In the control group, routine training (including control of disease complications, drug complications, insulin therapy, how to control blood sugar, diet, physical activities) will be provided to caregivers through educational pamphlets.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
General Administration of Martyr Foundation and Martyrs Affairs of Golestan Province
Full name of responsible person
Vaziri Esrafil
Street address
vila Ave, 5Azar Blvd
City
Gorgan
Province
Golestan
Postal code
4917758643
Phone
+98 17 3234 8551
Email
info@zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr.Khadige Rezaei kheykhaei
Street address
Rajaei Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Email
kh_rezaeikahkha@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Mohammad Maghsoudloo mahali
Position
Master of Science in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdowsi Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Fax
Email
m.Maghsoadloomahli@zbmu.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mohammad Maghsoudloomahali
Position
Master of Science in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdowsi Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Fax
Email
m.Maghsoadloomahli@zbmu.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mohammad Maghsoudloomahali
Position
Master of Science in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdowsi Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Fax
Email
m.Maghsoadloomahli@zbmu.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD