Protocol summary

Study aim
Determining the effect of family-centered empowerment model on daily life activities of elderly people with chronic obstructive pulmonary disease
Design
A randomized clinical trial with two intervention and control groups, with parallel, unblinded, randomized groups, and phase 3 on 224 elderly people, where four-way alternating blocks were used for randomization.
Settings and conduct
This study was conducted in the internal medicine clinics of Gonabad University of Medical Sciences. The family-centered empowerment model was implemented through four steps: perceived threat, problem solving, educational participation, and evaluation. Each step consisted of a 75- to 90-minute session. The sessions were conducted face-to-face with discussion, exchange of ideas, and questions and answers between the researcher, the patient, and the patient's primary caregiver. The activities of daily living questionnaire was completed by the elderly before the intervention and one week after the intervention.
Participants/Inclusion and exclusion criteria
Patient inclusion criteria: willingness to participate in the study, age 60 years and older, moderate to severe COPD diagnosed by an internal medicine specialist; Patient exclusion criteria: known psychological problems and problems affecting the elderly's daily activities, such as movement disorders and disabilities; Caregiver inclusion criteria: willingness to participate in the study, primary caregiver who provides the most help to the patient in treatment and care, having at least 6 months of experience caring for the patient, being literate
Intervention groups
In the intervention group, the family-centered empowerment model was implemented through four steps: perceived threat, problem solving, educational participation, and evaluation. Routine care was provided to the control group.
Main outcome variables
Activity of Daily Living

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241105063610N1
Registration date: 2025-04-05, 1404/01/16
Registration timing: registered_while_recruiting

Last update: 2025-04-05, 1404/01/16
Update count: 0
Registration date
2025-04-05, 1404/01/16
Registrant information
Name
Pegah Esmaeili
Name of organization / entity
The University of Gonabad
Country
Iran (Islamic Republic of)
Phone
+98 51 5223 9448
Email address
pegahesmaili430@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on daily living activities of the elderly with ‎Chronic Obstructive Pulmonary Disease
Public title
The effect of family-centered empowerment model on daily living activities of the elderly with ‎Chronic Obstructive Pulmonary Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Age 60 and above for seniors Moderate to severe chronic obstructive pulmonary disease diagnosed by an internist The primary caregiver who provides the most assistance to the patient in treatment and care. Have at least 6 months of patient care experience Being literate for the caregiver
Exclusion criteria:
Known psychological problems (mental illnesses/strokes) based on the patient's record and primary caregiver report Problems affecting the elderly's daily activities, such as movement disorders and disability, as observed by the researcher and self-reported by the patient and caregiver
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 224
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were assigned to two intervention and control groups using four-way permutation blocks. The intervention group will be assigned the letter "A" and the control group the letter "B". The possible states in the four-way block are six states including "AABB, BBAA, ABAB, BABA, ABBA, BAAB", each state will be written on a card and the cards will be assigned numbers one to six. Then, one of the six possible states will be selected using dice and the selected patients will be divided into two groups based on that. This process will continue until the sample size is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Approval date
2025-02-10, 1403/11/22
Ethics committee reference number
IR.GMU.REC.1403.070

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Activity of Daily Living
Timepoint
Before the intervention and one week after the intervention
Method of measurement
‎ Activities of Daily Living ‏ &‏Instrumental Activities of Daily Living

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, the family-centered empowerment model was implemented through four steps: perceived threat, problem solving, educational participation, and evaluation. Each step consisted of a 75- to 90-minute session. The sessions were conducted face-to-face with discussion, exchange of ideas, and questions and answers between the researcher, the patient, and the patient's primary caregiver.
Category
Rehabilitation

2

Description
Control group: No special training was provided for the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Internal Medicine Clinics of Gonabad University of Medical Sciences
Full name of responsible person
Dr.AbdolJavad Khajavi
Street address
Nurse Street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Phone
+98 51 5723 6843
Email
Bohloolipd@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr.Ali Firozi Chahak
Street address
Side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Phone
+98 51 5722 5027
Email
Bohloolipd@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Pegah Esmaeili
Position
Master student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Street gharani
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Phone
+98 51 5223 9448
Fax
+98 51 5722 3815
Email
pegahesmaili430@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Hosein Ajam
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Phone
+98 51 5722 5027
Email
moallef@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Pegah Esmaeili
Position
Master student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Street gharani
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Phone
+98 51 5223 9448
Fax
+98 51 5722 3815
Email
pegahesmaili430@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
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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