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Collaborative Nutrition Programs Involving Family Improve Nutritional Status And Self-Management Of Hemodialysis Patient
Last registered on September 03, 2019

Pre-Trial

Trial Information
General Information
Title
Collaborative Nutrition Programs Involving Family Improve Nutritional Status And Self-Management Of Hemodialysis Patient
RCT ID
AEARCTR-0004657
Initial registration date
September 01, 2019
Last updated
September 03, 2019 4:55 PM EDT
Location(s)
Primary Investigator
Affiliation
Hasanuddin University
Other Primary Investigator(s)
PI Affiliation
Hasanuddin University
PI Affiliation
Hasanuddin University
Additional Trial Information
Status
Completed
Start date
2019-04-30
End date
2019-06-30
Secondary IDs
Abstract
Background: One of the most common complications in patients with hemodialysis is malnutrition. Therefore it is necessary to manage basic nutrition because a number of patients have difficulty managing diets that adversely affect mortality and morbidity. The purpose of this study was to identify the effect of collaborative nutrition program interventions by involving families on nutritional status, self-management and family involvement. Method: The Randomized Control Trial research design with intervention group (n = 20) was given a collaborative nutrition program including nutritional assessment, diet management, education, and counseling every 2 weeks for 8 weeks and the control group (n = 19) was given education according to the standard. Results: In the intervention group, the Malnutrition Inflamation Score decreased from the initial measurement of 9.0 ± 1.94 to 5.2 ± 1.0 with a significance of p <0.001 compared to the results of the control group. Laboratory parameters Self-management increased from the initial measurement of 25.15 ± 2.66 to 31.95 ± 2.08 at eight weeks with a value of p <0.001 compared to the control group. Family involvement increased from the initial measurement of 23.10 ± 3.52 to 31.20 ± 2.11 with a p value <0.001 compared to the control group. Conclusion: Hemodialysis patients who are given a collaborative nutrition education program involving the family can improve nutritional status, self-management and family involvement
External Link(s)
Registration Citation
Citation
Adref, Ferry, Ariyanti Saleh and Syahrul Syahrul. 2019. "Collaborative Nutrition Programs Involving Family Improve Nutritional Status And Self-Management Of Hemodialysis Patient ." AEA RCT Registry. September 03. https://doi.org/10.1257/rct.4657-1.0.
Experimental Details
Interventions
Intervention(s)
Collaborative nutrition education programs include assessment, diet management, nutrition education for patients and families and counseling. In nutrition education researchers used the lecture method and group discussion in class with 5-10 participants. Education is provided by researchers and dietists registered with RD (Registered Dietisen) who have work experience of more than 5 years. Educational material includes general information on nutritional therapy, diets for hemodialysis patients, avoided foods and food illustrations, cooking tips for low sodium. Patient class is done at post hemodialysis while family class is done at intradialytic time with a duration of 15-30 minutes in each session. For patients with comorbidities and complications given additional information at individual counseling sessions. In the counseling session conducted collaboratively by researchers and nutrition counselors who already have nutritional counseling competencies in hospitals that have nutritional counseling experience more than 5 years. Counseling content that is restrictions on dietary patterns, changes in lifestyle and behavior related to nutrition, symptoms related to nutrition experienced, obstacles in eating, supporting factors in improving nutrition and efforts to manage / prepare food
Intervention Start Date
2019-04-30
Intervention End Date
2019-06-30
Primary Outcomes
Primary Outcomes (end points)
This study aims to identify the effect of collaborative nutrition program interventions by involving families on nutritional status, self-management and family involvement
Primary Outcomes (explanation)
Nutritional status includes Malnutrition Inflammation Score, Albumin, Sodium, Potassium and Chloride
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
This study was conducted with a quantitative approach with the research design used was Randomized Control Trial, there were intervention groups that were given collaborative nutrition education programs for 2 months and control groups were given hospital standard nutrition education procedures.
Experimental Design Details
Randomization Method
Public lottery
Randomization Unit
Sampling was done by simple random sampling in which a research assistant with nurses arranged a sampling frame by recording and sequentially recording the patient's name based on the hemodialysis schedule (days), then entering the day name and schedule in a closed envelope and then the researcher took the first two envelopes for the intervention group and the next two envelopes were taken back for the control group. The envelope containing the name of the day and schedule will be adjusted according to the patient undergoing hemodialysis on that day according to the inclusion criteria. Patients undergoing hemodialysis on that day were randomized again to meet the estimated number of samples for each group of 21 patients.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
92 patients undergoing hemodialysis
Sample size: planned number of observations
77 patients were randomized
Sample size (or number of clusters) by treatment arms
21 patients in the intervention group and 21 patients in the control group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The effect of intervention on variables of nutritional status, self-management and family involvement was determined by paired t-test with a p value <0.05 considered significant.
Supporting Documents and Materials
Documents
Document Name
Intervention methods
Document Type
other
Document Description
File
Intervention methods

MD5: 2f4ed2fbf1a8ba6f3b6ed234eb896662

SHA1: 29872a741d048c2892a6e77b64470ad3ca73ab79

Uploaded At: September 01, 2019

IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
the Health Research Ethics Committee of the Hasanuddin University Medical School
IRB Approval Date
2019-04-30
IRB Approval Number
318 / UN4.6.4.5.31 / PP36 / 2019
IRB Name
Ethics committee of Dr. H Chasan Boesoerie Ternate Hospital
IRB Approval Date
2019-04-27
IRB Approval Number
070/112 / IV / 2019
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
June 30, 2019, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
June 30, 2019, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
in the hemodialysis unit
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
39 patients undergoing hemodialysis
Final Sample Size (or Number of Clusters) by Treatment Arms
20 patients in the intervention group and 19 patients in the control group
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
No
Reports and Papers
Preliminary Reports
Relevant Papers