Evaluating the effect of Pender’s Health Promotion Model education on diabetic foot patients lifestyle and self-efficacy
Design
Double-blind, randomized community-based Clinical trial with pragmatic control group, with parallel groups
Settings and conduct
After obtaining permission from the Ethics Committee and the Research Council of Iran University of Medical Sciences, researcher will refer to the endocrine clinics of Rasoul Akram and Firoozgar Hospitals and People with diabetic foot ulcers who has all inclusion criteria will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with grade 1 or 2 of diabetes which should be diagnosed by his physicians.Patients with diabetic foot ulcers.Ability to read and write. Having 18 years of age or older. Not being employed in or graduate from Health Care affiliated courses. Ability to communicate. No history of caring of diabetic foot patients.
Exclusion criteria: absence of even one training session. Having Vascular Disease
Intervention groups
"Intervention group”: People with diabetic foot ulcer which has all the criteria for entering the research. The educational sessions were 4 and each 2 hours which were held in 2 weeks. At the end of sessions the booklet was given to the samples. Control group”: People with diabetic foot ulcer which has all the criteria for entering the research, The educational of this group is done with the usual method by the medical staff.
Main outcome variables
Diabetic foot ulcers education principles were used by researcher in the research environments
To change the lifestyle of patients with diabetic foot ulcers in research environments
To improve the self-efficacy of diabetic foot ulcers in research environments
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180726040606N1
Registration date:2019-01-05, 1397/10/15
Registration timing:retrospective
Last update:2019-01-05, 1397/10/15
Update count:0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
Parya Vakilian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4435 5764
Email address
mahmoudi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Pender’s Health Promotion Model on Life Style And Self Efficacy of Clients With Diabetic Foot
Public title
The Effect of Pender’s Health Promotion Model on Life Style And Self Efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 1 diabetes or 2 with medical diagnosis included in the case
Patients with diabetic foot ulcers
Literacy reading and writing
Aged 18 years and older
Unemployment or Graduate in Health Care
Ability to communicate
No history of diabetic foot scars
Exclusion criteria:
Not attending even in a training session
Vascular Disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In the process of selecting samples from a continuous method and Assignment of samples to the test and control group Blocked randomization method will be used. The researcher designed a 4-part package and Based on sample count, Possibilities of the test and control group in that package. The selection of samples from the test and control group is on the responsibility of the Nurses Which does not know the flow of the study. With her choice The distribution of samples is randomly assigned to the test and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be done in two blind ways. As a researcher when collecting information, The presence of samples in the test and control group is not known. On the other hand, samples are also unaware of being in the test and control group. This method increases the power of study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
No. 1, 13 Ave., Asgari Street., North Shahran
City
Tehran
Province
Tehran
Postal code
1478738933
Approval date
2018-04-07, 1397/01/18
Ethics committee reference number
IR.IUMS.REC.1397.339
Health conditions studied
1
Description of health condition studied
Clients with Diabetic Foot
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Study of lifestyle in diabetic foot ulcers
Timepoint
The beginning of the study (before the intervention) and 50 days after the intervention
Method of measurement
Health Promoting Lifestyle Profile II
Secondary outcomes
1
Description
Self-efficacy study in diabetic foot ulcers
Timepoint
The beginning of the study (before the intervention) and 50 days after the intervention
Method of measurement
Diabetic Foot Care Self Efficacy Scale
Intervention groups
1
Description
"Intervention group": For this group by lecturing and giving booklets training was done. The main dimensions of Pender’s model as nutrition, exercise, responsibility about his health, stress management (Identify Stress Resources, Stress management actions), Interpersonal support( Maintaining relationships with proximity), self actualization(Having a sense of purpose, Looking for personal progress and Self-knowledge and satisfaction experience). In the lecture method, firstly the test group is in the clinic classroom, Training related to Pender Health Promotion Model, Using Whiteboard and Powerpoint (The educational sessions were 4 and each 2 hours which were held in 2 weeks). At the end of sessions the booklet was given to the samples.In the first and fourth sessions the HPLP 2 and self efficacy instrument for diabetic foot patients were completed. Every 15 days Questions will be asked by the researcher on the educational materials of the samples(Within 50 days after intervention, The researcher will call you three times). After 50 days, samples in the dates that the researcher co-ordinated with them, They go back to the treatment centers. The mentioned tools will be completed again by the intervention group.
Category
Lifestyle
2
Description
"Control Group": In this group also completes the mentioned forms(HPLP 2 and self efficacy instrument for diabetic foot patients), Common trainings will be received by clinic staff before discharge. The group also returned to the clinic after 50 days, with previous coordination and The forms will be completed and Finally, the instruction book will be delivered to this group as well.