Protocol summary

Study aim
This study determines the effect of sleep health education with follow care pattern on elderly sleep quality that they are covered by the Gonabad health centers in 1398.
Design
This study is a randomized clinical trail in two parallel group.
Settings and conduct
Samples will select By systematic random method among the elderlies referring to Gonabad health centers. And with Blocked by random allocation method (Fourth block) will divide in to two groups: A) intervention, B) control. The main questionnaire (pre-test) is provided to the elderly by the researcher prior to the assignment of the subjects to the two groups. After the intervention, the post-test questionnaire is completed by someone other than him who is not aware of the group. Also, information analysis from the group will not be known.
Participants/Inclusion and exclusion criteria
older than 60, hearing and speaking health, cognitive health, the possibility to call with client. Also if the elderly man had depression, cancer, heart failure, severe lung disease, physical disability, chronic pain, Alzheimer, use another interventions to improve sleep quality, hospitalization during intervention, Unexpected event such as Close Death; he will exclude from the study.
Intervention groups
. After that for group A, a One-hour meeting will be held in health center and issues such as the importance of sleep in elderly's life, changes of sleep during aging, sleep health and effective factors on it Will be taught. Then In order to follow up, A phone call will be taken, twice a weak in the first month and once a weak in second month. For group B there won't be any intervention.
Main outcome variables
Elderly sleep quality improvement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190622043968N1
Registration date: 2019-07-06, 1398/04/15
Registration timing: retrospective

Last update: 2019-07-06, 1398/04/15
Update count: 0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
Maryam Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5652 5792
Email address
moradi.mf69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-08, 1397/11/19
Expected recruitment end date
2019-02-18, 1397/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sleep health education program with follow-up care method on elderly sleeps quality
Public title
The effect of sleep health education program on elderly sleeps quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
older than 60 hearing and speaking health cognitive health the possibility to call with client
Exclusion criteria:
the elderly man had depression, cancer, heart failure, severe lung disease, physical disability, chronic pain, Alzheimer use another interventions to improve sleep quality hospitalization during intervention Unexpected event such as Close Death
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will select By systematic random method among the elderlies referring to Gonabad health centers. And with Blocked by random allocation method (Fourth block) will divide in to two groups: A) intervention, B) control
Blinding (investigator's opinion)
Double blinded
Blinding description
1- The random allocation sequence is obtained by the methodologist with the software. 2- Experts appointed in the Gonabad Triple Centers register the elderly. The researcher will make a central list 3. An individual outside the team collects the codes and assigns them to the intervention and control groups based on the assignment sequence.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
University of Medical Sciences and Services, Seventh Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.SHMU.REC.1397.192

Health conditions studied

1

Description of health condition studied
sleep quality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sleep quality score based on Pittsburgh Sleep Inventory
Timepoint
Before the intervention begins 2 months after intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: . After that for group A, a One-hour meeting will be held in health center and issues such as the importance of sleep in elderly's life, changes of sleep during aging, sleep health and effective factors on it Will be taught. Then In order to follow up, A phone call will be taken, twice a weak in the first month and once a weak in second month.
Category
Treatment - Other

2

Description
Control group: For group B there won't be any intervention.Only routine health care will be provided
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
centerl Health Fayyazbakhsh
Full name of responsible person
Maryam Moradi
Street address
Imam Khomeini Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
36147-73947
Phone
+98 51 5652 5792
Email
moradi.mf69@gmail.com

2

Recruitment center
Name of recruitment center
Health Center No. 2
Full name of responsible person
Maryam Moradi
Street address
Edalat jonobi Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
36147-73947
Phone
+98 51 5652 5034
Email
moradi.mf69@gmail.com

3

Recruitment center
Name of recruitment center
Health Center No. 3
Full name of responsible person
Maryam Moradi
Street address
Naser Khosrow Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
36147-73947
Phone
+98 51 5652 5034
Email
moradi.mf69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology of Shahrood University of Science
Full name of responsible person
Dr. Mohammad Hassan Emamian
Street address
University of Medical Sciences and Services, Seventh Tir Square, Shahroud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
moradi.mf69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Shahrood University of Science
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
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Student Nursing Masters
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11, Shahid Bahonar 13, Farhangian Town
City
Bajestan
Province
Razavi Khorasan
Postal code
36147-73947
Phone
+98 895156525034
Email
moradi.mf69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahboubeh Khajeh
Position
Ph.D. Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences and Services, Seventh Tir Square, Shahroud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
m_khajeh@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11, Shahid Bahonar 13, Farhangian Town
City
Bajestan
Province
Razavi Khorasan
Postal code
36147-73947
Phone
+98 51 5652 5034
Email
moradi.mf69@gmail.com

Sharing plan

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be released after unidentifiable people
When the data will become available and for how long
Immediately after completing the plan
To whom data/document is available
All the researchers
Under which criteria data/document could be used
covered by the Gonabad health centers
From where data/document is obtainable
moradi.mf69@gmail.com Maryam Moradi
What processes are involved for a request to access data/document
Initially, an application is submitted via email, then after the email is read, if possible, the data will be provid
Comments
Loading...