Investigating the effect of weekly pill box usage on drug adherence in the elderly with cardiovascular disease referring to Kerman Social Security Clinic, 2017
Investigating of the effect of weekly pill box on drug adherence in the elderly with cardiovascular disease
Design
A randomized, controlled, parallel group, single blinded trial on 70 patients with cardiovascular disease
Settings and conduct
Referring to the Kerman Social Security Clinic, eligible patients were enrolled in the study. After completing the demographic and Morisky drug adherence questionnaires, the patients were assigned to the control or intervention groups. In the intervention group, the weekly pill box was provided to the patient and the medications were inserted for one week. The correct way of filling the box was trained to the patient and family member within three next weeks. The control group received routine care.
After one month, the drug adherence questionnaire was completed by all patients.
Blinding: The statistics analyst blinding was done by coding the groups and not registering any identifiers.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
60 years of age and older
Diagnosis of cardiovascular diseases such as hypertension, congestive heart failure, myocardial infarction, acute coronary syndrome, and atrial fibrillation
Not having cognitive disorders such as Alzheimer or other types of dementia
Physical ability to use the pillbox
Exclusion criteria:
Hospitalization
Unwillingness to continue participating in the study
Intervention groups
Intervention group: Patient's medications were placed in the weekly pill box and training interventions were provided to the patient and his family members about the correct way of filling the box in the next three weeks.
Control group: There was no intervention in the control group.
After one month, the drug adherence questionnaire was completed by all patients.
Main outcome variables
Medication adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027736N5
Registration date:2018-10-06, 1397/07/14
Registration timing:retrospective
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
shahin heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 5351
Email address
sh.heidari@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-05, 1396/07/13
Expected recruitment end date
2018-02-02, 1396/11/13
Actual recruitment start date
2017-10-12, 1396/07/20
Actual recruitment end date
2018-03-04, 1396/12/13
Trial completion date
2018-03-04, 1396/12/13
Scientific title
Investigating the effect of weekly pill box usage on drug adherence in the elderly with cardiovascular disease referring to Kerman Social Security Clinic, 2017
Public title
Effect of pillbox usage on drug adherence in elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cardiovascular disease such as hypertension, congestive heart failure, myocardial infarction, acute coronary syndrome, atrial fibrillation
Age 60 years or older
Ability to use pillbox
Exclusion criteria:
Being hospitalized
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are allocated randomly to the intervention or control group. So, code 1 is written on one card and code 2 is written on the other card. Of each sample, 35 cards are issued and qualified persons are assigned to the group by selecting one of the cards. The code one for intervention group and code two was considered as a control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was single blind and the analyzer was blind to the type of intervention. The blinding was that the data for the intervention group with code 1 and the intervention group data with code 2 were entered into the software without mentioning the type of intervention and were analyzed by an individual outside the research team.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Scinces Ethic Comitee
Street address
Rafsanjan University of Medical ScincesImam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717643373
Approval date
2017-10-03, 1396/07/11
Ethics committee reference number
IR.RUMS.REC.1396.97
Health conditions studied
1
Description of health condition studied
Drug non-compliance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug adherence
Timepoint
before intervention- One month after intervention
Method of measurement
Morisky 8 drug adherence questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, there was an intervention group and a control group. In the intervention group, the weekly pillbox, manufactured by the Spadana Medical Technology Company, was used for four weeks. This pill box had a separate transparent chamber for each day and four pillars for medications in the morning, noon, evening and night. The names of weekdays and hours of use of medications were included in each section.
Category
Other
2
Description
Control group: The control group received routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Payambar Azam Hospital clinic
Full name of responsible person
Mrs. Navid Asadi
Street address
Abuhamed street, payambar Azam Hospital, Kerman
City
Rafsanjan
Province
Kerman
Postal code
7618953764
Phone
+98 34 3226 0041
Email
Asadi_navid@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Shamsi
Street address
Imam ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0034
Email
info@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahin Heidari
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mofateh Street
City
Rafsanjan
Province
Kerman
Postal code
7717643373
Phone
+98 34 3425 5900
Email
sh.heidari@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ashraf Mehdinia
Position
Clinical Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abuhamed street
City
Kerman
Province
Kerman
Postal code
7717643374
Phone
+98 34 3226 0041
Email
a.babaki398@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzieh Loripoor
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Abuzar Street
City
Rafsanjan
Province
Kerman
Postal code
7717643378
Phone
+98 34 3425 6961
Email
marzeyehloripoor@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