NCT07240714

Brief Summary

The overall goal of this clinical trial is to learn if a web-based support programme can improve wellbeing in cardiac arrest survivors by helping them manage emotional, cognitive, and physical challenges. The study also explores how the programme is used and experienced in practice. The main questions it aims to answer are:

  • Can access to a web-based support programme improve overall wellbeing in cardiac arrest survivors?
  • Can it also enhance quality of life, cognitive function, life satisfaction, and sleep, while reducing anxiety, depression, post-traumatic stress, and fatigue? Researchers will compare cardiac arrest survivors who receive a web-based support programme in addition to standard care with those who receive standard care alone, to see if the programme improves wellbeing and other health outcomes. After the study, the control group will also gain access to the programme. Participants will:
  • Be asked to complete online questionnaires at three time points: at the start of the study, after 3 months, and after 6 months.
  • Be encouraged to use a web-based support programme for 3 months, with unlimited access, at their own pace and according to their individual needs (intervention group only).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Nov 2025Aug 2028

First Submitted

Initial submission to the registry

November 14, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

November 14, 2025

Last Update Submit

November 20, 2025

Conditions

Cardiac Arrest (CA)

Keywords

Cardiac arrestDigital support programmeWeb-based interventionMental wellbeingQuality of lifeFatigueCognitive functionAnxiety and depressionPost-traumatic stressRandomized controlled trialco-creation

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Overall Wellbeing at 3 months.

    The Questionnaire on Well-Being is a tool designed to capture subjective well-being. It consists of 18 questions, each rated from 0 to 4, which are added together to give a total score between 0 and 72. Higher scores reflect greater perceived well-being, while scores below 50 have been linked to significant psychological distress.

    From baseline to 3 months after enrollment.

Secondary Outcomes (8)

  • Change from Baseline in Quality of Life at 3 and 6 months.

    From baseline to 3 and 6 months after enrollment.

  • Change from baseline in Life Satisfaction at 3 and 6 months.

    From baseline to 3 and 6 months after enrollment.

  • Change from baseline in Anxiety at 3 and 6 months.

    From baseline to 3 and 6 months after enrollment.

  • Change from baseline in Depression at 3 and 6 months.

    From baseline to 3 and 6 months after enrollment.

  • Change from baseline in Post-Traumatic Stress at 3 and 6 months.

    From baseline to 3 and 6 months after enrollment.

  • +3 more secondary outcomes

Study Arms (2)

Web-Based Support Programme for Cardiac Arrest Survivors

EXPERIMENTAL
Behavioral: Digital Support Programme

Waitlist Control (Standard Care + Delayed Access)

NO INTERVENTION

Participants in this arm receive standard follow-up care according to national guidelines. They do not have access to the digital support programme during the study period. However, they are placed on a waitlist and are offered access to the programme after study completion.

Interventions

Digital Support ProgrammeBEHAVIORAL

The intervention consists of a web-based support programme designed for individuals recovering from cardiac arrest. Participants in the intervention group receive access to the programme for 12 weeks. The programme includes educational modules, patient and family stories, videos, practical exercises (e.g., breathing techniques, fatigue management), tools for personal recovery planning, and a moderated chat forum for peer support. Participants can access the content at their own pace and according to their individual needs. The programme is delivered entirely online and does not require any physical visits or clinical procedures.

Web-Based Support Programme for Cardiac Arrest Survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Survival of a cardiac arrest 1 to 3 months prior to enrollment
  • Access to a mobile phone, tablet, or computer with internet connection

You may not qualify if:

  • Insufficient language or cognitive ability to engage with a digital intervention and complete questionnaires in Swedish
  • Participation in another study involving the collection of patient-reported outcome measures (PROMs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dept of Cardiology

Linköping, Sweden

Location

Dept of Cardiology

Motala, Sweden

Location

Dept of Cardiology

Norrköping, Sweden

Location

MeSH Terms

Conditions

Heart ArrestFatigueAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc professor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 21, 2025

Study Start

November 20, 2025

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be made available to members of the research team after the principal investigator has completed blinded analyses of the primary and secondary outcomes. Data will be stored securely and access will be restricted to authorized collaborators under data use agreements.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning after completion of the blinded primary and secondary outcome analyses by the principal investigator, with no defined end date.
Access Criteria
Access to de-identified individual participant data (IPD) will be granted to members of the research team after completion of the blinded analysis of primary and secondary outcomes by the principal investigator. Each researcher must submit a brief description of the planned analyses and sign a data use agreement outlining responsibilities for data handling, confidentiality, and publication ethics. Access requests will be reviewed and approved by the principal investigator.

Locations

SE(3)