The effect of implementing a self-management program based on Model 5A on self-management ability and symptoms of heart failure in the elderly with chronic heart failure
The effect of self-management program based on 5A model on self-management ability and Symptoms of heart failure of the elderly with chronic heart failure
Design
A randomized clinical trial with community based and control group, non-blind. For randomization, the method of non-transparent sealed envelopes with random sequence will be used.
Settings and conduct
This study will be performed on the elderly with heart failure. In the intervention group, a self-management program based on Model 5A (including five stages: Assess, Advise, Agree, Assist and Arrange) will be implemented.
This program includes theoretical and practical training, as a program with the pursuit of behavioral goals set during 12 weeks (in the1st week, 1st, 2 and 3 stage will performed in an individual session, in the 2 and 3 week, will performed 4 stage in a group and an individual session and the 5 stage will performed from 4 to 12 week of follow-up in Face-to-face meeting and phone call by researcher. Data will be collected using a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: over 60 years; At least a third of secondary education; Lack of hearing and speech disabilities; Class 2 and 3 heart failure; No previous training in the field of self-management; passing at least six months of the disease; Being treated with heart failure drugs; Being in cognitive health condition. ٍExclusion criteria: Changes in medications taken during the intervention; Having a fatal disease (eg, cancer); Having a severe chronic illness (such as obstructive pulmonary disease, asthma);
Intervention groups
Conventional care will be performed in the control group. In the intervention group, the self-management program based on 5A model will be implemented.
Main outcome variables
Self-management ability and symptoms of heart failure in the elderly with heart failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211122053151N1
Registration date:2021-12-27, 1400/10/06
Registration timing:prospective
Last update:2021-12-27, 1400/10/06
Update count:0
Registration date
2021-12-27, 1400/10/06
Registrant information
Name
Darya Shojaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
dar.shojaee@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementing a self-management program based on Model 5A on self-management ability and symptoms of heart failure in the elderly with chronic heart failure
Public title
The effect of self-management program based on 5A model on self-management ability and Symptoms of heart failure of the elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years At least a third of secondary education the city of Babol and related countryside areas
Have cognitive health based on the Abbreviated Mental Test (AMT), ability to perform daily life activities (using ADL daily life activities tool)
Having second- and third-degree heart failure who have been ill for at least six months.
Do not have severe chronic illness (such as obstructive pulmonary disease, asthma (affecting the severity of respiratory symptoms and fatigue)
Exclusion criteria:
Participation of individuals in similar studies
Having a fatal disease (eg, cancer)
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sequentially (numbered, opaque, sealed envelopes)
In this study, samples will be assigned to the intervention and control groups using sealed envelopes. In this way, 40 cards with the english letter A and 40 cards with the english letter B will be prepared and placed in sealed envelopes, and each patient will choose one of these cards at random without insertion, and if The choice of the letter A will be in the intervention group and if the card B is selected in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of social welfare and rehabilitation sciences
Street address
University of Social Welfare and Rehabilitation Sciences, koodakyar Blvd, Daneshjoo Stre, Evin Ave, Tehran.
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.USWR.REC.1400.212
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Self-management ability
Timepoint
Before and after intervention
Method of measurement
Self-management ability scale (SMAS)
2
Description
Fatigue severity
Timepoint
Before and after intervention
Method of measurement
Fatigue severity scal(FSS)
3
Description
Dyspnea
Timepoint
Before and after intervention
Method of measurement
Modified Medical Research Council(MMRC)
Secondary outcomes
1
Description
Hypertention
Timepoint
Before and after intervention
Method of measurement
Blood pressure machine
Intervention groups
1
Description
Intervention group: The self-management program based on model 5A, which includes 5 stages of assess, advise, agree, assist and arrange, will be implemented in the intervention group. In the first stage or assess, the problems of each person are identified, in the second stage based on the results of previous stage, the client is instructed about the problems and stressors. In the third stage or agree, the researcher and the client agree on the behavioral goals and plans to achieve those goals. In the fourth stage or assist, advice is given based on the needs of patients, by face-to-face oral instruction or handing out brochures. Finally, in the fifth stage, Follow-up will be done by phone and visit in the clinic. This program includes theoretical and practical training, as a program with the follow up of behavioral goals set during 12 weeks. In the first week, stage 1 ,2 and 3 will performed in an individual meeting (90 minutes). In the second and third week, will performed stage 4 in a group meeting (2 hours) and an individual meeting (60 minutes) and the stage 5 will performed from fourth to twelfth week of follow-up in next 2 months by phone call (daily phone call, in the first two weeks; twice a week phone call, in the next two weeks and then monthly calls) and face-to-face meeting (every four weeks).
Category
N/A
2
Description
Control group: The control group will receive the usual training (what is routinely taught in the clinic; such as reading educational pamphlets if desired).