FeasibilityNCT05503810
Social Support Intervention Targeting Patients Treated for Cardiac Disease Who Experience Loneliness
A study testing Social support in people with Feasibility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Introduction: In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness is lacking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility
- What is being tested?
- Social support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Oct 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients treated for Ischemic heart disease (CABG or PCI), valve disease (TAVR, SAVR), and arrhythmia (ICD, pacemaker implantation or ablation) treated at Rigshospitalet and classified as high risk lonely according to the High Risk Loneliness (HiRL) tool
Who cannot join
- Patients who are unable to provide written consent, therefore, patients with severe cognitive or physical dysfunction will not be approached
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Randomized Trial of a Social Support Intervention Plus Usual Care Versus Usual Care, Targeting Patients Treated for Cardiac Disease Who Experience Loneliness
Introduction: In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness is lacking.
Aim: To determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness.
Read more
Design: A feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up). Intervention: Patients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the six months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline, one, three and six months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consolations will be based on Middle-range theory of self-care.
Outcome: Feasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors and health outcomes will be evaluated in the intervention and the control group at baseline, one, three, six and twelve months.
- Conditions
- Feasibility
- Being tested
- Social support
- Keywords
- Loneliness, Social support, cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social supportBehavioural
Also called Loneliness reduction
Contact ones a week with Informal caregiver or peer support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Six month social support intervention following in hospital cardiac treatment Receives: Behavioral: Social support |
| Control | No intervention | Regular follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Acceptability
Percentage of eligible patients who agree to participate in the trial
Measured: Measured at baseline
Feasibility, Adherence
Percentage of patients in contact with the informal caregiver at least once a week face to face, by phone or virtually.
Measured: 6 months follow-up after in-hospital cardiac treatment
Secondary outcomes (3)
Measure of social network members as informal caregivers
Percentage of potential caregivers who accepts to be an informal caregiver
Measured: Measured at baseline
Measure of informal caregivers
Percentage of informal caregivers participating in all three intervention consultations with the trial staff
Measured: 3 months follow-up after in-hospital cardiac treatment
Resource consumption
Time resources used to complete the three nurse consultations
Measured: 6 months follow-up after in-hospital cardiac treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start5 Oct 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: Study not feasible. Acceptance rate was too low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FeasibilityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial design with 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selina Kikkenborg Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Selina K Berg, Professor, Principal investigator, Copenhagen University Hospital, RigshospitaletMitti Blakø, PhD, Study director, Copenhagen University Hospital, RigshospitaletAnne V Christensen, PhD, Study chair, Copenhagen University Hospital, RigshospitaletPernille Palm, PhD, Study chair, Copenhagen University Hospital, RigshospitaletIda E Hojskov, PhD, Study chair, Copenhagen University Hospital, RigshospitaletCamilla Bernild, PhD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503810
- Sponsor's protocol ID
- HeartBuddyPilot
- Status last verified
- Nov 2023
- First submitted
- 10 Aug 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blakoe M, Olesen CS, Christensen AV, Palm P, Hoejskov IE, Berg SK. The rise and fall of a social support intervention feasibility trial targeting loneliness in patients with cardiac disease - lessons learned and future perspectives. BMC Nurs. 2024 Jun 24;23(1):423. doi: 10.1186/s12912-024-02113-6.
PubMed 38910234Blako M, Christensen AV, Hojskov IE, Palm P, Berg SK. Protocol for a feasibility randomized trial of a social support intervention plus usual care versus usual care, targeting patients treated for cardiac disease who experience loneliness. Pilot Feasibility Stud. 2023 Feb 6;9(1):22. doi: 10.1186/s40814-023-01255-9.
PubMed 36747245
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Randomized Trial of a Social Support Intervention Plus Usual Care Versus Usual Care, Targeting Patients Treated for Cardiac Disease Who Experience Loneliness
- ClinicalTrials.gov ID
- NCT05503810
- Acronym / sponsor ID
- HeartBuddyPilot
- Conditions
- Feasibility
- Keywords
- Loneliness, Social support, cardiac
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study not feasible. Acceptance rate was too low.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness is lacking.
Aim: To determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness.
Design: A feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up). Intervention: Patients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the six months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline, one, three and six months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consolations will be based on Middle-range theory of self-care.
Outcome: Feasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors and health outcomes will be evaluated in the intervention and the control group at baseline, one, three, six and twelve months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial design with 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Social supportSix month social support intervention following in hospital cardiac treatment |
| Control | No intervention | –Regular follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated for Ischemic heart disease (CABG or PCI), valve disease (TAVR, SAVR), and arrhythmia (ICD, pacemaker implantation or ablation) treated at Rigshospitalet and classified as high risk lonely according to the High Risk Loneliness (HiRL) tool
Key exclusion criteria (1 listed)
- Patients who are unable to provide written consent, therefore, patients with severe cognitive or physical dysfunction will not be approached
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social supportAlso: Loneliness reductionContact ones a week with Informal caregiver or peer support | Behavioural | Intervention |
Primary outcome
Feasibility, Acceptability
Time frame: Measured at baseline
Percentage of eligible patients who agree to participate in the trial
Feasibility, Adherence
Time frame: 6 months follow-up after in-hospital cardiac treatment
Percentage of patients in contact with the informal caregiver at least once a week face to face, by phone or virtually.
3 secondary outcomes
Measure of social network members as informal caregivers
Time frame: Measured at baseline
Measure of informal caregivers
Time frame: 3 months follow-up after in-hospital cardiac treatment
Resource consumption
Time frame: 6 months follow-up after in-hospital cardiac treatment
Results and safety
The study was stopped early (reason given: Study not feasible. Acceptance rate was too low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 38910234Blakoe M, Olesen CS, Christensen AV, Palm P, Hoejskov IE, Berg SK. The rise and fall of a social support intervention feasibility trial targeting loneliness in patients with cardiac disease - lessons learned and future perspectives. BMC Nurs. 2024 Jun 24;23(1):423. doi: 10.1186/s12912-024-02113-6.
- Derived from this study: PubMed 36747245Blako M, Christensen AV, Hojskov IE, Palm P, Berg SK. Protocol for a feasibility randomized trial of a social support intervention plus usual care versus usual care, targeting patients treated for cardiac disease who experience loneliness. Pilot Feasibility Stud. 2023 Feb 6;9(1):22. doi: 10.1186/s40814-023-01255-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina K Berg, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
Mitti Blakø, PhD study director
Copenhagen University Hospital, Rigshospitalet
Anne V Christensen, PhD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social support in people with Feasibility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study not feasible. Acceptance rate was too low.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, Acceptability (time frame: Measured at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.