x

We are happy to announce that all trial registrations will now be issued DOIs (digital object identifiers). For more information, see here.
The effect of education and family empowerment on low salt diet adherence in the elderly with high blood pressure
Last registered on August 20, 2019

Pre-Trial

Trial Information
General Information
Title
The effect of education and family empowerment on low salt diet adherence in the elderly with high blood pressure
RCT ID
AEARCTR-0004600
Initial registration date
August 19, 2019
Last updated
August 20, 2019 9:35 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
Sawerigading Nursing Academy
Other Primary Investigator(s)
PI Affiliation
Hasanuddin University
PI Affiliation
Hasanuddin University
Additional Trial Information
Status
Completed
Start date
2019-04-08
End date
2019-06-21
Secondary IDs
Abstract
Aim. To find out the extent of the effect of education and family empowerment on elderly adherence in implementing a low salt diet.
Method: Randomized, controlled trial study design. The number of respondents was 30 elderly respondents with high blood pressure in the work area of the Batua Health Care Center in Makassar City, Indonesia, respondents were randomized and divided into two groups. Group one, education and family empowerment training programs, group two act as a control group. The instrument used; the Indonesia version of the "Salt intake reduction questionnaire (SIRQ)” with α cronbach 0.85 consists of three components; attitudes and subjective standards subscales; behavioral control and perceived perception control, Compact Salt Meter (salt concentrate in food), KME-03 salinity checker (urine salt concentrate), Muranaka portable Sphygmomanometer to measure blood pressure, and family support questionnaire. The intervention group received health education accompanied by one family member, and the development of knowledge, psychomotor, and adherence improvement, exercise intervention was provided through regular meetings and the control group received standard educational procedures. The statistical test used was the Independent T test and one-way Repeated Anova test. Data analysis uses SPSS version 21.0 (IBM Corp.).
Results: Group education and family empowerment showed levels of adherence; attitudes, subjective norms and perceived behavioral control and family support significantly increased after education and regular meetings were held (p <0.05). Salt concentrations in food and urine also show significant results. The control group of all variables did not show significant improvement or results (p> 0.05). The education and family empowerment group reports that reducing salt while cooking can make feeling lighter and healthier. Through education training and family empowerment effectively increases adherence to the adoption of a low salt diet and can be applied to family communities that have elderly people with high blood pressure at home.
External Link(s)
Registration Citation
Citation
Arafat, Rosyidah, Andi Masyitha Irwan and Suharno Usman. 2019. "The effect of education and family empowerment on low salt diet adherence in the elderly with high blood pressure." AEA RCT Registry. August 20. https://doi.org/10.1257/rct.4600-1.0.
Experimental Details
Interventions
Intervention(s)
Group one, education and family empowerment training programs, group two act as a control group
Intervention Start Date
2019-04-21
Intervention End Date
2019-06-16
Primary Outcomes
Primary Outcomes (end points)
Group education and family empowerment showed levels of adherence; attitudes, subjective norms and perceived behavioral control and family support significantly increased after education and regular meetings were held (p <0.05). .
Primary Outcomes (explanation)
The variable of item I subscale attitudes and item II of the subjective norm subscales statistically have increased over time (P <0.05). item 3 subscale compliance with statistically controlled behavioral controls has decreased statistically over time to the time.
The family said it had tried to reduce the use of seasoning such as Monosodium Glutamate (MSG). They start gradually from the previous habit of up to 2 tablespoons of salt used in a day, being a reminder and controller for the elderly when cooking by taking the time to choose food ingredients, cooking low-salt menu to eat together, trying to get involved in implementing a low-salt diet menu , and filling in the activity sheet the amount of salt used when cooking, family participants also said "My family and I have started to use kitchen spices if for example the taste is still not good, such as orange leaves, onion / white, cayenne pepper, star fruit , bay leaves, etc. "and the food tastes good. The response of family and elderly participants said "After I tried using 1 teaspoon salt (6 grams / day) it felt much better, the head which usually feels heavy becomes lighter and the feeling becomes better than before."
The education and family empowerment group reports that reducing salt while cooking can make feeling lighter and healthier. Through education training and family empowerment effectively increases adherence to the adoption of a low salt diet and can be applied to family communities that have elderly people with high blood pressure at home
Secondary Outcomes
Secondary Outcomes (end points)
Salt concentrations in food and urine also show significant results. The control group of all variables did not show significant improvement or results (p> 0.05)
Secondary Outcomes (explanation)
Salt concentration in food and urine significantly decreased the mean score after education and training, can be seen in figures 6 and 7, but after one month routine meetings rose again, compared to the control group which tended to be stagnant with the average concentration of salt in food and urine remained high from the beginning to the end of the meeting. Systolic and diastolic blood pressure variables in the two groups did not experience a statistically significant change (p> 0.05), but in the intervention group, after clinical education and training there was a decrease in blood pressure (blood pressure variability was very much a contributing factor and was not used as an outcome major in this research study).
Experimental Design
Experimental Design
Randomized, controlled trial study design. The number of respondents was 30 elderly respondents with high blood pressure in the work area of the Batua Health Care Center in Makassar City, Indonesia, respondents were randomized and divided into two groups. Group one, education and family empowerment training programs, group two act as a control group.
Experimental Design Details
Group one, routine education training programs and empowerment family, group two act as a control group. The intervention group received regular health education, and the development of knowledge, psychomotor and increased adherence, as well as understanding the importance of family involvement in implementing a low salt diet, the control group received standard educational procedures.
Randomization Method
Researchers prepare 36 pieces of paper containing numbers 1-36 according to the number of initial formulation then the paper is folded then put into a container and randomized, then every participant who comes and meets the criteria is asked to take one sheet of paper was then inserted again into a number so that the proportion is maintained, participants who take even numbers will be used as an intervention group, as well as in the second location the elderly who take odd numbers will be used as a control group.
Randomization Unit
Individual by area
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
We chose three different three locations and equal characteristic, two adjacent locations were made as the first location and acted as an intervention group while one location that was far apart from the two previous locations was used as a control group aimed at preventing contamination between group, and based on the inclusion and exclusion criteria
Sample size: planned number of observations
36 participant. Identified control group (n = 18), intervention (n = 18)
Sample size (or number of clusters) by treatment arms
Identified 30 participants who met the criteria inclusion. Recruitment is done when the elderly integrated service is carried out in each area. Flowchart of participants in this RCT study
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
Documents
Document Name
Instrument Questionnaire
Document Type
survey_instrument
Document Description
This document material is Instrument ; the Indonesia version of the "Salt intake reduction questionnaire (SIRQ)”
File
Instrument Questionnaire

MD5: 3f2bca1458cc36d7406568a1e0ee26bd

SHA1: f9a0206963b583ee48b0dcb162e99feafea6348d

Uploaded At: August 19, 2019

IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
IRB Approval Date
IRB Approval Number
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers