Protocol summary

Study aim
The effect of "nurse telephone follow-up" on "self-care ability" and "fatigue severity" of the elderly with COPD
Design
Clinical trial with control group, with parallel groups, single blind, randomized, phase 3 on 70 patients. Randomized block design was used for randomization.
Settings and conduct
Place of study: Pulmonary Department of Shahid Sayad Shirazi Hospital Blinding is a type of blinding ( evaluator of study outcomes)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Seniors 60 to 75 years old Diagnosis of chronic obstructive pulmonary disease based on medical records Having sufficient literacy and knowledge to complete the questionnaires Having the minimum physical and cognitive ability to perform self-care measures based on the abbreviated cognitive test (AMT) Having a cell phone or landline available Non-entry criteria: A score of less than 7 on the Abbreviated Cognitive Test (AMT) due to cognitive difficulties Having a serious and limiting medical problem such as cancer and...
Intervention groups
In the intervention group, in addition to face-to-face training, telephone follow-up will also be implemented for 3 months. Phone calls will be made twice a week. The conversation time between 9 am and 12 noon, the duration of each conversation will be recorded. The content of the conversations includes self-introduction, questions about the patient's general health status and answers to the patient's questions about the management and health status, encouraging the patient to comply with the recommendations made and providing advice on the use of drugs and nutrition and sports and providing support in Times will be necessary. In the control group: they will receive face-to-face training sessions and usual and routine care, but they will not be followed up by phone.
Main outcome variables
Fatigue intensity and self-care

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT20170108031818N6
Registration date: 2024-03-10, 1402/12/20
Registration timing: prospective

Last update: 2024-03-10, 1402/12/20
Update count: 0
Registration date
2024-03-10, 1402/12/20
Registrant information
Name
fatemeh mehravar
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 893 7199
Email address
mehravar10261@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of "nurse telephone follow-up" on "self-care ability" and "fatigue severity" of the elderly with chronic obstructive pulmonary disease (COPD)
Public title
Investigating the effect of "nurse telephone follow-up" on "self-care ability" and "fatigue severity" of the elderly with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly 60 to 75 years Diagnosis of chronic obstructive pulmonary disease based on medical records Having sufficient literacy and knowledge to complete the questionnaires Informed consent to participate in the study Having the minimum physical and cognitive ability to perform self-care measures based on the abbreviated cognitive test (AMT) Having a cell phone or landline available Not having hearing limitations
Exclusion criteria:
A score of less than 7 on the Abbreviated Cognitive Test (AMT) due to cognitive difficulties Having a serious and limiting medical problem such as cancer and... Lack of access to mobile phone or registered phone Having hearing impairment
Age
From 60 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Participates in the study will be assigned to two intervention (B) and control (A) groups using Block Randomization. In this way, by using a dice that has 6 faces, the samples are assigned to their groups, a number is written on each face, and each number is assigned to one of the blocks of the table, which shows its special state. The control group (has face-to-face training but no phone follow-up) and the intervention group (has face-to-face training and is followed up by phone by a nurse). The complete list of randomized blocks will be provided to the principal investigator by the study epidemiology consultant.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in this study is single blind. So that the patient knows which treatment group he is in, but the fatigue intensity and self-care evaluator (Investigator) will not be informed of the patient's treatment group. So that the evaluator of the outcome variables of the study is not the student himself (the main implementer of the project) and a nurse colleague who does not know about the study design is used.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Shasat Kolah St., Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.GOUMS.REC.1402.467

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Fatigue intensity
Timepoint
3 times (before starting the study, immediately after the face-to-face training sessions and after completing the telephone follow-up)
Method of measurement
Fatigue Severity Scale Questionnaire (FSS)

2

Description
Elderly self-care
Timepoint
3 times (before starting the study, immediately after the face-to-face training sessions and after completing the telephone follow-up)
Method of measurement
Elderly Self-Care Ability Questionnaire (SASE)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to face-to-face training, telephone follow-up will also be implemented for 3 months (by the researcher). In this way, phone calls will be made twice a week. The conversation time between 9:00 AM and 12:00 PM, the duration of each conversation will be recorded and at the end of the phone call, the time of the next conversation will be determined with the agreement of the patient. The content of the conversations includes self-introduction, questions about the patient's general health status and answers to the patient's questions about the management and health status, encouraging the patient to comply with the recommendations made and providing advice on the use of drugs and nutrition and sports and providing support in Times will be necessary. Also, necessary recommendations will be given to the patient and his questions will be answered.
Category
Lifestyle

2

Description
Control group: They will receive face-to-face training sessions and usual and routine care, but they will not be followed up by phone. It should be noted that all elderly patients with chronic obstructive pulmonary disease in this study received the usual treatment of the disease, including activity, medication and diet. They receive the recommended food.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayad Shirazi Hospital, Gorgan
Full name of responsible person
Ghanbar Rouhi
Street address
Shasat Kolah St., Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
mehravar10261@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges beigom Mirbehbahani
Street address
Shasat Kolah St., Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
mehravar10261@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
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
Gorgan University of Medical Sciences
Full name of responsible person
Ghanbar Rouhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shasat Kolah St., Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
Mehravar10261@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ghanbar Rouhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shastakola Street, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
0173243319
Email
mehravar10261@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Mehravar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Shasat Kala. Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
mehravar10261@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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