NCT03267953

Adaptive Internet-based Stress Management Among Adults With a Cardiovascular Disease: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design

Completed NA Last updated 4 November 2019

What this trial tests

NA trial testing My Health CheckUp Online Stress Management Program in Cardiovascular Diseases in 59 participants. Completed in 31 August 2019.

Timeline

30 October 2017

Primary endpoint
28 February 2019

31 August 2019

Quick facts

Lead sponsor	St. Mary's Research Center, Canada
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	supportive care
Enrollment	59
Start date	30 October 2017
Primary completion	28 February 2019
Estimated completion	31 August 2019
Sites	1 location across Canada

Drugs / interventions tested

• My Health CheckUp Online Stress Management Program
• Lay telephone coaching
• Motivational interviewing (telephone)

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Stress, Psychological — all drugs for Stress, Psychological →

Sponsor

St. Mary's Research Center, Canada — full company profile →

Who can join

18 and older, any sex, with Cardiovascular Diseases or Stress, Psychological. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Internet-based stress management programs adapted to patients' needs

Stress is inevitable, and it has many negative consequences on the health of everybody, but particularly on the health of patients with a cardiovascular disease (CVD). The good news is that patients with CVD can learn to better control their stress through stress management programs. Most stress management programs are offered face-to-face by a trained health care professional. Research has shown that these programs have a positive impact on the health of patients with CVD, including reducing mortality and other risk factors that can make the disease worse (e.g., reduces blood pressure). Because of these benefits, the recommendation is to offer a stress management program to as many patients with CVD as possible. The problem is that their delivery is challenging for most clinics (e.g., too costly to run, health care professionals are not available). This means many good stress management programs never make it to the patient. Patients also face barriers in accessing traditional stress management programs such as stigma or need to travel. Therefore, new approaches are needed to allow findings from research to actually have an impact on the public's health.

One of these approaches is to use the internet to deliver stress management programs. The internet has now been used for about 10 years to deliver a range of programs to patients. There are limitations to this approach as well. For instance, 40-60% of patients who will use an internet-based program will not benefit from it. These patients need more support or guidance to get the most out of their internet-based program. This is the problem addressed using the proposed innovative trial design. Investigators aim to improve the number of patients with CVD who improve after receiving a stress management program by changing the type and level of support they receive over time. This type of innovative trial design is more and more popular, but has never been used to enhance a stress management programs for patients with CVD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.