To determine the effect of the partnership care model on the quality of life and the activity of daily living among stroke patients
Design
This study is a clinical trial with two intervention and control groups. Patients are randomly (lottery technique) allocated into two groups and the study is single blind.
Settings and conduct
This study is carried out at the Rafideh Rehabilitation Comprehensive Hospital, affiliated to the University of Welfare Sciences in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Stroke patients under rehabilitation at Rofaydeh Rehabilitation Hospital;
Age over 60 years;
Passed two weeks from the acute treatment period;
Desire and ability to communicate and decide
Exclusion Criteria:
Heart Failure class III and IV;
Malignancies requiring chemotherapy.
Intervention groups
Intervention group 1: Partnership educational visits: these visits are done weekly, with the participation of 4 to 6 homogeneous patients and the presence of nurses and physicians, in order to motivate and prepare patients to participate in the care and treatment process. Intervention group 2: Follow-up partnership visits: these visits are done monthly, at least for 6 months, in order to do follow up the adherence and continuing the participation.
Control group: during at least two weeks of hospitalization, these patients are visited by physicians every day and in the case of occurrence and diagnosis of a problem, rehabilitation interventions are done.
Main outcome variables
Patients' Quality of life; Activity of daily living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180930041185N1
Registration date:2018-11-03, 1397/08/12
Registration timing:prospective
Last update:2018-11-03, 1397/08/12
Update count:0
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Eesa Mohammadi
Name of organization / entity
Faculty of Medical Sciences Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3585
Email address
mohamade@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of "Partnership Care Model" on quality of life and activity daily living in Patients' Cerebrovascular accident
Public title
Effect of the Partnership Care Model in Patients with cerebrovascular accident
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 2 weeks history of treatment for Stroke
Being at the age of 60 years old and more
Willing to take part in the study
Ability of communication and decision making
Exclusion criteria:
Heart failure (class III , IV)
Having malignancies requiring chemotherapy
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of subjects is done by the randomization technique lottery. As 80 cards are numbered for 80 patients and placed in a basket. Then two blank envelopes are determined, one as intervention and one as control. Then, by drawing cards from the basket, some numbers are selected alternately for the two envelopes. Then the patients admitted the hospital receive a number based on their reception order (based on the cards in the pockets).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of the study groups they are allocated to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University/Regional Research Ethics Committee
Street address
No. 21, First Besat Ave., West Fathemi Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.NIMAD.REC.1397.236
Health conditions studied
1
Description of health condition studied
Stroke / Cerebrovascular Accident
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Patients' Quality of Life Score based on SF-36 questionnaire
Timepoint
Measurements are done before the intervention, one month after completing the first phase of intervention, and then for up to 6 months, monthly in each follow-up visit.
Method of measurement
Short Form- 36 (SF-36) Questionnaires related to quality of life
2
Description
Activity of Daily Living Score based on The Lawton Criteria
Timepoint
Measurements are done before the intervention, one month after completing the first phase of intervention, and then for up to 6 months, monthly in each follow-up visit.
Method of measurement
The Lawton Questionnaire to measure the ٍElderly's Activity of Daily Living
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive stroke care and treatment based on partnership care model (PCM). After assessment and recording basic information (demographic variables, care requirements and problems highlighted in the first step of PCM), the care program will prepared and implemented for the intervention group in accordance with the PCM. The program has two phases: (i) an educational partnership meeting; and (ii) a follow-up partnership meeting. In the first phase, at least three educational partnership will be held at the rehabilitation centers weekly; the partnership comprised of 4–6 patients, a nurse and a physician. The nurse will be the leader of the team and the chair of the meetings. The physician will support the patients in decision making. The purpose of these meetings will be motivating and making the patients ready. In the first meeting, the nature, causes and complications of CVA will be introduced to the patients. The second meeting will address non-drug therapy (nutrition and activity regimens). In this meeting, nutrition and activity regimens will be arranged, evaluated and justified for each participant in response to his/her questions, level of distress, condition and status. In the third meeting drug therapy for underlying diseases such as high blood pressure and diabetes will be discussed. Prescription drugs, their effects, their usage and dosage, their importance and side effects will be discussed in addition to address patient's anxiety and answer any questions about the drugs. In the second phase, follow-up partnership meetings will be held monthly in the rehabilitation center for 6 months. These meetings will be held by the partnership of 4–6 patients, the nurse and the physician. The goal of the meetings will be to encourage, support and evaluate the patient compliance and participation during care. At each meeting, in the first 40–45 minutes, blood pressure will be taken and problems with the disease will be considered and addressed, new prescriptions or nutrition regimens will be offered, and previous medical care intervention will be evaluated. The SF-36 & ADL questionnaires are also completed by patients in each session.
Category
Rehabilitation
2
Description
Control group: Patients in the control group include stroke patients who receive routine care at the rehabilitation center. These patients are screened and hospitalized at least one month after the attack by the physician.After determining the needs and problems of rehabilitation, physiotherapist or speech therapist referral and rehabilitation is performed, then they are discharged at most after three weeks.They will visited by a researcher at the center. These patients, like the patients in the intervention group, have been visited by a research associate to complete the questionnaires' the quality of life and the Activity of Daily Living at specified intervals.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofaydeh Rehabilitation Hospital
Full name of responsible person
Dr. Feridon Layeghi
Street address
Neamati Alley, Shahid Soliamani Ave, Ghiatariea
City
Tehran
Province
Tehran
Postal code
10209
Phone
+98 21 2220 5326
Fax
+98 21 2223 2741
Email
rofeideh.hospital@uswr.ac.ir
Web page address
http://rofeideh.uswr.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr. Reza Malekzadeh
Street address
No. 21, First Besat Ave. West Fathemi Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Fax
+98 21 6690 0920
Email
NIMAD@RESEARCH.AC.IR
Web page address
http://nimad.ac.ir/
Grant name
Elite Grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
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
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Eesa Mohammadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way
City
Tehran
Province
Tehran
Postal code
14115-333
Phone
+98 21 8288 3585
Fax
+98 21 8288 3550
Email
mohamade@modares.ac.ir
Web page address
http://www.modares.ac.ir/~mohamade
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medical Sciences of Tarbiat Modares University
Full name of responsible person
Eesa Mohammadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bridge Nasr (Ghisha), Jalale Al-Ahmad Great Way.
City
Tehran
Province
Tehran
Postal code
14115-333
Phone
+98 21 8288 3585
Fax
+98 21 8288 3550
Email
mohamade@modares.ac.ir
Web page address
http://www.modares.ac.ir/~mohamade
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medical Sciences of Tarbiat Modares University
Full name of responsible person
Eesa Mohammadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way
City
Tehran
Province
Tehran
Postal code
14115-333
Phone
+98 21 8288 3585
Fax
+98 21 8288 3550
Email
mohamade@modares.ac.ir
Web page address
http://www.modares.ac.ir/~mohamade
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
I must provide all information for the sponsoring institution.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
No application
When the data will become available and for how long
No application
To whom data/document is available
No application
Under which criteria data/document could be used
No application
From where data/document is obtainable
No application
What processes are involved for a request to access data/document