Protocol summary

Study aim
determine the effect of Continuous care model on elderly's sleep quality.
Design
Semi-experimental study with control group
Settings and conduct
This semi-experimental study was conducted in two groups of control and intervention on the elderlies referred to the senior-citizen center of Zirab, Mazandaran province in 2017
Participants/Inclusion and exclusion criteria
the membership in the senior-citizen center of Zirab, the willingness to cooperate, the age of 60-80 years, and no participation in other self-care programs affecting the quality of sleep simultaneously with the present study
Intervention groups
The continuous care model was implemented in the intervention group, which consists of four stages of orientation, sensitization, control and evaluation.Considering the barriers to elderly sleep in orientation and sensitivity of the elderly to this , intervention was carried out. In the control stage, the intervention was reviewed and corrected if necessary. The control group did not receive any intervention and was followed up during this period, but after effective in the intervention group, the control group also performed
Main outcome variables
the quality of sleep in the elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180303038931N1
Registration date: 2018-05-29, 1397/03/08
Registration timing: retrospective

Last update: 2018-05-29, 1397/03/08
Update count: 0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Mahsa Kamali
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 11 4227 7819
Email address
kamali2n@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-10, 1396/02/20
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Continuous Care Model on the Elderly's Sleep Quality
Public title
The Effect of Continuous Care Model on the Elderly's Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
the membership in the senior-citizen center of Zirab the willingness to cooperate the age of 60-80 years no participation in other self-care programs affecting the quality of sleep simultaneously with the present study
Exclusion criteria:
Unwillingness to cooperate Having an acute illness that is undergoing hospitalization
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Medical Sciences, Tarbiat Modares University
Street address
Bridge nasr- Jalal Al-e Ahmad -Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR-TMU-REC-1395.460

Health conditions studied

1

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

Primary outcomes

1

Description
sleep quality
Timepoint
Before the intervention, one month and two months after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Continuous care model was implemented in four phases in their .Considering the barriers to elderly sleep in the stage of orientation and sensitivity of the elderly to this, intervention was carried out. In the control stage, the intervention was reviewed and corrected if necessary. Between 5-8 sessions with the presence of the elderly family on modifying the sleep pattern, including fluid restriction, sleep acceleration techniques, relaxation methods, and so on. The intervention lasted 6 weeks.
Category
Lifestyle

2

Description
Control group: The control group did not receive additional intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The Association of Retirees of the Zirab City in Mazandaran Province
Full name of responsible person
Lotf Ali Faraj Nejad
Street address
The main square of the city - beside the mosque
City
Zirab
Province
Mazandaran
Postal code
4817817598
Phone
+98 11 4245 1847
Email
kamali2n@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Khavanin Ali
Street address
Nasr Bridge-Jalal Al Ahmad -Tehran
City
Teran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3849
Email
khavanin@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Mahsa Kamali
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mahyar Ave, Taleghani Blvd
City
Sari
Province
Mazandaran
Postal code
4817817598
Phone
+98 11 4227 7819
Email
kamali2n@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fazlollah Ahmadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bridge nasr-Jalal Al-e Ahmad -Tehran
City
Tehran
Province
Tehran
Postal code
331 -14115
Phone
+98 21 8288 3553
Email
ahmadif@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mahsa Kamali
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mahyar Ave, Taleghani Blvd
City
Sari
Province
Mazandaran
Postal code
4817817598
Phone
+98 11 4227 7819
Email
kamali2n@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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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