Comparative study of using drug reminder cards with telephone follow-up on drug adherence of the elderly with hypertension referred to comprehensive health service centers in Rafsanjan in1401
Design
Control group with two parallel groups, randomized by minimization, sample size of 40 people per group
Settings and conduct
The reminder card is designed by the researcher and provided to the first intervention group.
Phone Reminder Telephone Call is performed in pre -coordinated times in the second intervention group. Control group does not intervene
Participants/Inclusion and exclusion criteria
Inclusion criteria
Seniors 60 to 75 years old
Suffering from high blood pressure according to the doctor's opinion
Taking antihypertensive drugs
Ability to read and write
Not suffering from Alzheimer's and other types of dementia
Physical ability (movement-vision-hearing) to take medicines independently
Not using other types of drug reminders
Exclusion criteria
being admitted to the hospital
Change in the mental state and alertness of a person due to a disease such as CVA
Unwillingness to continue participating in the study
Failure to answer the phone more than twice
Failure to attend the health center once a month
Intervention groups
Control Group, routine care for blood pressure treatment will be done in accordance with the routine of comprehensive health services centers. The drug card intervention group, weekly medication cards will be designed and provided to the patient. The telephone tracking group follows the researcher how to take medications through telephone calls.
Main outcome variables
medication adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027736N6
Registration date:2022-10-04, 1401/07/12
Registration timing:registered_while_recruiting
Last update:2022-10-04, 1401/07/12
Update count:0
Registration date
2022-10-04, 1401/07/12
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
2022-07-03, 1401/04/12
Expected recruitment end date
2022-11-03, 1401/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of using drug reminder cards with telephone follow-up on drug adherence of the elderly with hypertension
Public title
Comparative study of using drug reminder cards with telephone follow-up on drug adherence of the elderly with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Seniors 60 to 75 years old
suffering from high blood pressure according to the doctor's opinion
taking antihypertensive drugs
being able to read and write
not suffering from Alzheimer's and other types of dementia
physical ability (movement-vision-hearing) to take medicines independently
Not using other types of drug reminders
Exclusion criteria:
being admitted to the hospital
Change of mental state and alertness of a person due to a disease such as CVA
Unwillingness to continue participating in the study
Failure to answer the phone more than twice
Failure to attend the health center once a month
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, include gender and scores of Morisky medication adherence scale-8. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables. The following table is used as a randomization tool:
Variables Category : Intervention group (pill card) * Intervention group
(phone call)*Control group
morrisky medication adherence scale-8(MMAS-8)
score
A score of 0 to 6 is adherence
Score 8 to 6
Moderate adherence
A score 8 high adherence
sex: female male
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
Research Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Nurse Street, College of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2022-06-22, 1401/04/01
Ethics committee reference number
IR.RUMS.REC.1401.063
Health conditions studied
1
Description of health condition studied
Drug adherence in the elderly with high blood pressure
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Drug adherence in the elderly with high blood pressure
Timepoint
At the beginning of sample collection, one, two, three months after the start of the intervention
Method of measurement
Morisky medication adherence questionnaire, demographic information questionnaire, pill counting form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Medication reminder card، Weekly drug reminder cards are designed by the researcher and given to the patient according to the review of the available texts and booklets and based on the drugs used by the patient. Considering that the intervention lasts for 3 months, 12 cards are designed for each person over time and according to the changes in the drugs used. The information on these cards includes the name of the drug, a clear color picture of the pill, the number of pills per dose, the reason for using it with a color picture (for example, the picture of a sphygmomanometer for antihypertensive medicine), the time/time of using the medicine using the picture or The pictograph will be the time of day and night (morning, noon, night, bedtime). Two copies of each reminder card are given to the patient and it is recommended to place each one in the most visible places. (For example, on the refrigerator door, inside the bedroom or on the prayer mat...)
Category
Behavior
2
Description
Intervention group: Telephone call group.The researcher keeps track of how the drugs are taken through phone calls. In this way, the nurse calls all the people at the pre-arranged time and reminds them of the name of the medicine, the dose of the medicine, the time of taking the medicine and the considerations when taking the medicine. The duration of the conversation is considered to be 5 to 10 minutes on average for each person, which varies based on the needs and educational questions of the patients. The phone call time will be set between 8:00 am and 8:00 pm with the agreement of the patients. The call schedule is provided to the patient in writing. The number of phone calls to follow up adherence to medication will be 2 times a week in the first month and once a week during the second and third months. If the first call is missed, the second call will be made on the same day. If the second call is also missed, the last call will be made the next day. Telephone follow-up is done for 3 months based on studies (33, 34). Telephone conversations will be recorded in the set form.
Category
Behavior
3
Description
Control group: In the control group, routine blood pressure treatment activities and care will be performed according to the routine of comprehensive health service centers.