Adherence to Nutritional Treatment Following MI Using Telemedicine Treatment (ADNUT)

NCT05498844 | Completed

• 1 other identifier: SMC-8448-21
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Background and aim: Cardiovascular diseases (CVDs) are the leading cause of death and disability worldwide. Although cardiac rehabilitation (CR) is an effective modality that reduces the risk for death, hospital readmissions and improves the quality of life (QoL), only a third of the patients participate in CR. The association between individual nutrients and dietary patterns such as the Mediterranean diet (MedDiet) have been shown to reduce the risk of myocardial infarction (MI) and mortality. Every 1-point increase in Mediterranean diet score is associated with a 12% decrease in mortality. Although physical activity and nutrition counseling are core components of CR, less than a third of remote CR programs provide nutrition counseling. In the current study, we aim to compare the effectiveness of remote, web-based nutrition counseling (WBNC) to standard in-person nutrition counseling (IPNC). Methods: Patients one month or less from hospital discharge for MI, who are capable of conducting a conversation using Zoom software, will be eligible to participate. In a single-blind, controlled single-center study, a 1: 1 randomization will be performed for web-based nutrition counseling (WBNC) intervention or standard in-person nutrition counseling (IPNC). Patients from both groups will receive the usual CR program (medical follow-up and on-site physical activity). Interventions will be delivered at baseline, 45 days, and 90 days post-baseline. Follow-up assessments will be performed at 6 months. Patients will complete questionnaires for socioeconomic information, physical activity level, motivation to perform lifestyle changes, food intake, adherence to MedDiet and QoL. Anthropometric measures and handgrip strength will be obtained. Medical information, lipid profile and fasting glucose level will be obtained from patient's records. Calculated sample size: 90 patients to reject the null hypothesis (no difference in between-group adherence to MedDiet) with 80% power and a confidence interval of 95%. Expected results: The effectiveness of WBNC on adherence to MedDiet, anthropometric measures, and Qol. Our findings will enable us to identify target populations for whom nutritional treatment using telemedicine will achieve optimal results. Importance to Medicine: Remote nutrition counseling has the potential to increase the accessibility and participation of patients, thus reducing gaps in medical service, hospitalizations, complications, and mortality. If proven beneficial, remote treatment will also allow for continuity of treatment during emergencies and closure.

Conditions

Cardiovascular Diseases; Acute MI

Keywords

Cardiovascular disease prevention; Digital cardiac rehabilitation; Medical Nutrition Therapy; Mediterranean diet score

Outcome Measures

Primary Outcomes (1)

• Increase in I-MEDAS score

  change in mean I-MEDAS score of 2 units

  6 months

Secondary Outcomes (1)

• Adherance to nutrition treatment

  6 months

Other Outcomes (1)

• Muscle strength

  3 MONTHS

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Control group participants will receive usual medical, physical activity, and standard in-person nutrition counseling (IPNC) on site.

Behavioral: Medical Nutrition Therapy (counselling)

Intervention-remote nutrition councelling

EXPERIMENTAL

Intervention group participants will receive remote, web-based nutrition counseling (WBNC) in addition to the standard medical counseling and on-site physical activity.

Behavioral: Medical Nutrition Therapy (counselling)

Interventions

Medical Nutrition Therapy (counselling) BEHAVIORAL

Participants will receive nutrition counseling to enhance adherence to the principles of the Mediterranean diet and support the achievement of adequate levels of lipid control, blood pressure and weight.

Intervention-remote nutrition councelling; Treatment as usual

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients within one month from hospital discharge for PTCA/MI,
• Patients with cardiac risk 1-2
• Patients capable of conducting a conversation using Zoom software
• Patients speaking either Hebrew or English

You may not qualify if:

• Patients with a prognosis of one year or less due to comorbidity
• Patients with renal failure or patients with hemodynamic instability
• Patients who were already participating in a remote cardiac rehabilitation program
• Patients with hearing or vision impairments are prevented from reasonable participation in an online call (zoom) or patients
• Patients who do not have access to a computer/smartphone.

Sponsors & Collaborators

• Ariel University: lead
• Sheba Medical Center: collaborator
• Soroka University Medical Center: collaborator

Study Sites (1)

Sheba, Tel Hashomer Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Nutrition Therapy; Counseling

Intervention Hierarchy (Ancestors)

Therapeutics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robert Klempfner, MD, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Nutrition Sciences

Model Details: In a single-blind, randomized controlled, single-center study, Individuals will be randomized to intervention or control groups by stratified randomization where the stratification will be by cardiac risk level and sex. All eligible patients fulfilling the eligibility criteria will be randomly sampled from the clinic lists. These patients will be contacted by study personnel after approval from the treating physician and asked to come for a baseline meeting and explanation of study procedures. Those meeting all inclusion criteria and willing to provide informed consent will be enrolled. A log will be kept of refusals and reasons for refusal.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: August 21, 2022
• Primary Completion: August 25, 2024
• Study Completion: August 25, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)