Adherence, Medication Clinical Trial
— CDIPMABPOfficial title:
Cognitive Dissonance Based Intervention to Promote Multivitamin Adherence on Bariatric Patients
Verified date | March 2021 |
Source | Universidad Autonoma de Baja California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project has a parallel randomized controlled experimental design since within the methodology there will be a control of the conditions under study, that is, the selection of subjects, the way the treatment will be administered, the way in which the observations will be obtained, the use of instruments to perform the measurements and the interpretation of the criteria will be implemented in a homogeneous manner. Convenience sampling was used to obtain the subjects for the study, the sample size was 34 bariatric patients from a private bariatric center in Tijuana, Baja California, Mexico. Participants were randomly assigned to one of two groups. The group understudy or experimental or the control group on the waitlist; that is, no researcher or study participant made the decision of treatment that participants receive. The intervention consists of two psychoeducative sessions and five cognitive dissonance sessions. All participants will receive the same multivitamin for the duration of the study. Validated tests for adherence, medication knowledge, self-care, self-efficacy, and psychopathological symptoms were applied to both groups. Additionally, a blood sample was collected for the determination of Hemoglobin, Iron, Copper, Zinc, Calcium, Phosphate, Vitamin D, and Folate. Measurements using tests and blood samples will be made before and after receiving the intervention [pre and post-test]. For results analysis, Repeated measures ANOVA will be used, the study population shall be stratified into subgroups, by type of bariatric surgery, age, and sex; this in order to restrict comparisons to participants who are part of the same subgroup. The aim of the study is to assess the impact of an intervention based on the cognitive dissonance theory to promote adherence to the bariatric multivitamin. The hypothesis of the study is: Participants exposed to Festinger's theory-based intervention will exhibit changes in their attitude and behavior towards multivitamin intake as a product of cognitive dissonance.
Status | Active, not recruiting |
Enrollment | 34 |
Est. completion date | May 24, 2021 |
Est. primary completion date | April 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Nationality: Mexican. - Place of Residence: City of Tijuana. - Bariatric techniques: Gastric Sleeve or Bypass Roux in Y. - Time after surgery: at least 6 months. - Agree to participate voluntarily by leaving it under signature in the informed consent format. Exclusion Criteria: - Nationality: foreign - Patients who do not reside in the city of Tijuana permanently. - Bariatric techniques other than Gastric Sleeve or Bypass Roux in Y. - Time: having passed less than 6 months post-operative. - Patients who have a cognitive disorder that limits learning or attendance at sessions. - Patients who are suspended by prescription from vitamin consumption. - Patients with any post-bariatric surgery complications that are under treatment. - Patients with a history of alcoholism. - Pregnant patients. - Patients who practice high-performance exercise. - Patients who do not consent to participate. |
Country | Name | City | State |
---|---|---|---|
Mexico | Universidad Autónoma de Baja California | Tijuana | Baja California |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Baja California |
Mexico,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapy adherence using the MBG (Martin-Bayarre-Grau) Questionnaire | Adherence of the participants to the multivitamin given, using an instrument validated for the Mexican population. The instrument is based on a Lickert scale, all questions have 5 possible answers that go from Never to Always and have respective values of 0 - 5, the total of the answer points is then recategorized to 0-17 No adherence, 18-37 Partial Adherence, and 38-48 Total Adherence. | Change from Baseline Adherence level at 3 months | |
Primary | Serum Iron, Copper and Zinc levels assessed by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) | Participants serum levels of Iron, Copper and Zinc in micrograms per deciliter | Change from Baseline Iron, Copper and Zinc levels at 3 months | |
Primary | Serum Calcium, Phosphate, levels measured by Colorimetric Spectroscopy | Participants serum levels of Calcium and Phosphate in milligrams per deciliter | Change from Baseline Calcium and Phosphate levels at 3 months | |
Primary | Serum Albumin and Total Protein levels measured by Colorimetric Spectroscopy | Participants serum levels of Albumin and Total Protein in grams per deciliter, the Albumin/Globulin Ratio will also be calculated as: Albumin/(Total Protein-Albumin). | Change from Baseline Albumin and Total Protein levels at 3 months | |
Primary | Serum Vitamin D and Folate levels measured by Enzyme-Linked ImmunoSorbent Assay (ELISA) | Participants serum levels of Vitamin D and Folate in nanograms per mililiter. | Change from Baseline Vitamin D and Folate levels at 3 months | |
Primary | Hemoglobin levels measured by the Hematology Analyzer | Participants Hemoglobin levels in grams per deciliter will be obtained using an Hematology Analyzer with a Reagent-Less method. | Change from Baseline Hemoglobin levels at 3 months | |
Secondary | Self-Care Capacity assessed using the Self-care Agency Appreciation (SAA) | Participants Self-Care Capacity obtained by the Self-care Agency Appreciation (SAA) test that was adapted and validated to be used in Mexican population. The test consists of 24 reagents and aims to assess self-care capabilities by representing all power components.
The response pattern of this questionnaire includes four options: total disagreement 1, disagreement 2, agreement 3, and total agreement 4. Each individual gets a score ranging from 24 to 112, where the higher the score higher the Self-Care Capacity. |
Change from Baseline Self-Care levels at 3 months after psychological intervention | |
Secondary | Self-Efficacy assessed using the General Self-Efficacy Scale (GSE) | Participants level of Self-Efficacy using the validated General Self-Efficacy Scale (GSE), adapted and validated to be used un Mexican population. The test has 10 questions and is based on a Likert scale, with the answer options Not at all true, Hardly true, Moderately true, and Exactly true, each answer scores from 1 to 4. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy. | Change from Baseline Self-Efficacy levels at 3 months after psychological intervention | |
Secondary | Psychopathological symptoms assessed using the Symptom Checklist-90-Revised (SCL-90-R) | Participants referred Psychopathological symptomps will be assessed using the Symptom Checklist-90-Revised (SCL-90-R) which contains the following Symptom Scales: Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, Psychoticism and some Global Indices like: Global Severity Index (GSI): Designed to measure overall psychological distress, Positive Symptom Distress Index (PSDI): Designed to measure the intensity of symptoms and Positive Symptom Total (PST): Reports number of self-reported symptoms. | Change from Baseline Psychopathological symptoms at 3 months after psychological intervention | |
Secondary | Knowledge of the Multivitaminic supplement assessed using a questionnaire to assess patient knowledge of their medicines | The participants Knowledge of the Multivitaminic supplement will be assessed using a test that consists of 11, open questions that gather the patient's knowledge about the therapeutic objective, the process of use, safety and conservation of the medicines that the patient uses. The answers are evaluated by a pharmacist classifying it as follows Incorrect : Score -1, Does not know: Score 0, Insufficient: Score 1 and Correct: Score 2.
For the final calculation of total drug knowledge (global PKM) a formula is applied in which each question scored differently based on the conclusions drawn in the different qualitative techniques. The global CPM was categorized into: No knowledge. 0 points, Insufficient knowledge. 0.60 to 1.26 points, Sufficient knowledge. 1.27 to 1.60 points, Optimal knowledge. 1.60 to 2 points. |
Change from Baseline Knowledge score at 3 months after psychological intervention |
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