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BENEFIT for all: The Ecosystem for Healthy Living

A stepped-wedge randomized cluster trial to evaluate the implementation of a personal health environment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20054
Enrollment
650
Registered
2020-03-09
Start date
2020-01-13
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

The BENEFIT intervention is a multifaceted lifestyle modification program that is offered in addition to standard, face-to-face, cardiac rehabilitation care. The program utilizes environmental rewards

Sponsors

Leiden University, LUMC, Vital10
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients referred to cardiac rehabilitation (i.e., people who have had a heart or brain incident, or who, according to Dutch guidelines, have an increased risk of cardiovascular disease of =10%)

Exclusion criteria

Exclusion criteria: 1. People with severe somatic and / or psychiatric co-morbidity which impedes participation according to the care provider's judgment. 2. People who do not have an email address and/or people who do not have the necessary digital skills to use their email address and fill out online questionnaires. 3. Non-Dutch speaking persons

Design outcomes

Primary

MeasureTime frame
1.(Maintenance of) Healthy lifestyle behavior in five domains: physical activity, smoking, alcoholic beverage consumption, diet, stress and stress-management activities, and sleep.

Secondary

MeasureTime frame
1. Physical health: relevant CVD risk factors such as cholesterol, diabetes, abdominal circumference, blood pressure and weight. 2. Quality of life: physical functioning, role functioning, social functioning, mental health, health perceptions and pain. 3. Cost-effectiveness: economic evaluation in terms of cost-per quality-adjusted life-year (QALY) taking into account mobility, ability to self-care, ability to undertake usual activities, pain/discomfort, and anxiety/depression. In addition we will explore the following: 1. Psychosocial health: depressive symptoms, anxiety symptoms and social support. 2. Motivation and self-efficacy: patients are requested to formulate at least one specific lifestyle goal in one of the six healthy lifestyle behavior domains. Outcome is the patient’s level of (intrinsic and extrinsic) motivation and self-efficacy to reach this goal and the patients’ stage-of-change he/she is in. 3. BENEFIT intervention evaluation: degree of therapy compliance, platform use, engagement and satisfaction with the digital platform

Contacts

Public ContactAndrea Evers

Leiden University

a.evers@fsw.leidenuniv.nl+31 71 527 6891

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)