main purpose: Evaluating the effect of smartphone software-based self-management training on the quality of life of people with Parkinson's
Sub-objectives:
1- Evaluation of quality of life and its dimensions in patients with Parkinson before, one month, three months after intervention
2- Comparison of quality of life and its dimensions in patients with Parkinson before, one and three months after the intervention
Practical goals: If the positive effect is confirmed, the smartphone software will be provided to the clients and their families.
Design
Clinical trial without control group, phase two, conducting on 77 patients.
Settings and conduct
quasi experimental study in neurologic clinics of Selected medical education Centers of Iran University of Medical sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-People with PD with recorded medical records, able to read and write, and use smartphone software. If the patient was not able, qulified carer will be used.
- are in the mild and moderate stages of the disease
Exclusion criteria:
- Death of the client, Hospitalization due to other diseases during the intervention
- Progression of the disease according to the clinical criteria of Hohann Yaher to stage 5 (stage of absolute disability)
- Reluctance of the client / caregiver to continue participating in the study
Intervention groups
Smartphone software containing self-management information was at once provided to the intervention group and follow up for 12 weeks.
Main outcome variables
Quality of life and its aspects in Parkinson's disease.
General information
Reason for update
Acronym
PDQ (parkinson disease quality of life)
IRCT registration information
IRCT registration number:IRCT20220417054561N1
Registration date:2022-08-07, 1401/05/16
Registration timing:retrospective
Last update:2022-08-07, 1401/05/16
Update count:0
Registration date
2022-08-07, 1401/05/16
Registrant information
Name
kosar zeighami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5592 2771
Email address
kzeighami76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
2021-07-23, 1400/05/01
Actual recruitment end date
2021-10-23, 1400/08/01
Trial completion date
2022-01-21, 1400/11/01
Scientific title
Evaluation of the effect of smartphone software based Self Management Education on the quality of life in Parkinson's disease patients
Public title
Evaluation of the effect of smartphone software based Self Management Education on the quality of life of Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with Parkinson's disease whose disease has been confirmed by a neurologist and recorded in their medical records.
Being in the mild and moderate stage of the disease (stages 1, 2, 3 and 4).
Have the ability to read and write, and use smartphone software.
Exclusion criteria:
Existence of active diseases such as cancer
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
77
Actual sample size reached:
77
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
It is a quasi-experimental one-group study (intervention group with 77 samples) that is designed to evaluate the effect of self-management education through software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran university of medical sciences, Ethics Committee in Biomedical Research
Street address
No.14, Building no.4, group 114, Moradi street, dolat abad, shahre-rey.
City
Tehran
Province
Tehran
Postal code
18598-35841
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.IUMS.REC.1400.132
Health conditions studied
1
Description of health condition studied
Parkinson`s disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
quality of life in parkinson`s disease
Timepoint
assessing quality of life before, 1 and three months after onset of intervention
Method of measurement
Parkinson`s Disease Quality of life Questioner (PDQ-36)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The self-management content provided by the smartphone software was provided from up-to-date, evidence-based medical, nursing, and rehabilitation sources. The accuracy, precision, and validity of this information was confirmed by three faculty members of the School of Nursing and Midwifery of Iran University of Medical Sciences. To conduct this quasi-experimental study, there was a need for an application that could be installed on a smartphone running the Android operating system, which could be used online and offline. The main features of this software are: educational content related to 1- Familiarity with the nature of the disease and motor and non-motor symptoms (general view of the disease) 2- Treatment methods, follow-up recommendations and adherence to medical and pharmaceutical treatment, Monitoring symptoms, 3- Self-management measures in physical symptoms (imbalance, gait disturbance and freezing, brady Keynesian, stiffness and tremor, muscle cramps, dyskinesia, tremor, masked face), 4- Self-management measures in symptoms Non-physical (cardiovascular problems, sleep and fatigue, mood and cognition, memory and concentration, gastrointestinal symptoms, nutrition management, urinary symptoms, self-efficacy, social support), 5- Talk to families (to prepare and improve home conditions , And supporting the family in using the software and accompanying the patient's family in self-management) 6- Frequently asked questions, 7- Contacting the caring nurse (researcher); This software, called "Parkin Seven", was divided into 7 parts and presented 7 recommendations in each part, was provided to the research units. All information in the software is based on scientific evidence and extracted from sites and scientific journals and authoritative books related to the subject and was provided to the clients at once by the smartphone software. Due to dyskinesia and other complications (such as tremors and visual disturbances) related to the disease and restrictions on the use of smartphones, images and text could magnify. This software is designed to inform patients and their families by providing information about the disease, symptoms, symptom management, treatment, and self-care training in the form of text and photos.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Hazrat-e- Rasool Hospital
Full name of responsible person
Alice Khachian
Street address
facculty of nursing and midwifery of iran university of medical sciences, Yasemi street, Vali-e-asr Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
Email
alicekhachian@hotmail.com
2
Recruitment center
Name of recruitment center
Neurology Clinic of Firoozgar Hospital
Full name of responsible person
Alice Khachian
Street address
facculty of nursing and midwifery of iran university of medical sciences, Yasemi street, Vali-e-asr Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
Email
alicekhachian@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Street address
facculty of nursing and midwifery of iran university of medical sciences, Yasemi street, Vali-e-asr Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
fnm@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
The statistical data are based on the Parkinson's Quality of Life Questionnaire, which has eight dimensions. By sharing statistical methods, the score of each dimension of the questionnaire and the overall quality of life score are also shared. Other characteristics, such as demographic information, will be unrecognizable.
When the data will become available and for how long
The access period will start after the results are published.
To whom data/document is available
Any findings from these results will be available to everyone.
Under which criteria data/document could be used
Academic researchers will be allowed to access and perform any analysis and use to improve the quality of care, rehabilitation, and quality of life for patients.
From where data/document is obtainable
Interested researchers can receive them by sending an e-mail to kzeighami76@gmail.com, stating the purposes of accessing the documents. With the permission of the responsible author, Dr. Khachian, the file will be sent to them. In addition, in the publication of their research, that have been done with the help and use of the documents of this research, accurate reference should be made.
What processes are involved for a request to access data/document
Interested researchers can receive them by sending an e-mail to kzeighami76@gmail.com, stating the purposes of accessing the documents.