Healthy aging through internet counseling in the elderly

Not Applicable

Completed

• Conditions: Cardiovascular prevention; Circulatory System

• Registration Number: ISRCTN48151589
• Lead Sponsor: Academic Medical Centre Amsterdam (Netherlands)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27288376 protocol 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29358447 qualitative sub-study results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31175194/ qualitative sub-study results (added 02/06/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32764085/ qualitative study results (added 10/08/2020) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/33323224/ results (added 17/12/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/35385395/ Factors predicting engagement in the intervention (added 07/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-05
• Study Completion: 2018-01-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2724

Inclusion Criteria

1. Age = 65 years
2. Available informant
3. = 2 cardiovascular risk factors and/or manifest cardiovascular disease defined as:
3.1. Cardiovascular risk factors:
3.1.1. Hypertension, defined by any of the following:
3.1.1.1. Diagnosis by specialist or GP
3.1.1.2. Currently on anti-hypertensive drugs
3.1.1.3. Baseline BP: if < 80 years: = 140/90 mmHg; if = 80 years: Systolic BP = 160
3.1.2. Dyslipidemia, defined by any of the following:
3.1.2.1. Diagnosis of dyslipidemia by specialist or GP
3.1.2.2. Use of lipid-lowering drug (this will include persons who have no dyslipidemia, but use it after a previous cardiovascular disease; this is acceptable, since these people automatically fulfil inclusion criteria as well)
3.1.2.3. Baseline total cholesterol = 5 mmol/L and/or LDL = 2.5 mmol/L
3.1.3. Overweight, defined by any of the following:
3.1.3.1. BMI = 30
3.1.3.2. Waist circumference men =102 cm, women =88 cm
3.1.4. Active smoking (self-reported, any tobacco use)
3.1.5. Lack of physical exercise (self-reported) defined as below the WHO norm of 30 minutes 5 times a week (or a total of 150 minutes per week) of intermediate exercise
or
3.2. History of cardiovascular disease:
3.2.1. Stroke/transient ischemic attack (TIA)
3.2.2. Myocardial infarction
3.2.3. Angina pectoris
3.2.4. Peripheral arterial disease
3.2.5. Diabetes mellitus (DM)

Exclusion Criteria

1. Previously diagnosed dementia as diagnosed by a GP or specialist
2. Mini Mental State Examination score <24
3. Any condition expected to limit 18-months compliance and follow-up
4. Computer illiteracy, defined as unable to send an email and/or do a simple Google search
5. Severe visual impairment interfering with operating a computer
6. Participating in another randomised controlled trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The primary endpoint of the study is a weighted composite score based on z-scores of the difference between baseline and 18 months follow-up values of systolic blood pressure, cholesterol and BMI. The rationale behind this primary outcome is that:<br> 1. 18-months follow-up is too short for a significant number of clinical outcome events even when using this sample size<br> 2. Only measurable risk factors are included (self-reported factors such as physical exercise are sensitive to bias)<br> 3. This will allow for very sensitive and direct assessment of the risk factors we target<br> This has the potential caveat of making a type I error, but even a very small effect on cardiovascular risk profile could have considerable effect at the population level (prevention paradox).<br>