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Completed

NCT Number: NCT04245228

Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Caregiver Burden

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

About this study

This is a randomized trial of health coaching compared to usual care. Caregivers for patients on the adult heart or adult lung transplant waiting list at the Mayo Clinic will undergo informed consent. Consenting participants will be randomized to weekly, 30-minute telephone calls for twelve weeks or usual care. Questionnaires and demographic information will be collected at baseline and after 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older who are the primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester and Jacksonville, FL

Exclusion criteria

  • Individuals younger than 18 years
  • Non-English speaking, non-verbal, or extremely hard of hearing

Treatment and study plan

Wellness Coach

Behavioral

Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention

Primary outcomes

  1. Acceptability

    Time frame: after completion of the 12-week intervention or between 12-16 weeks after enrollment

    Percentage of participants who completed the study intervention

Secondary outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: after completion of the 12 week intervention or between 12-16 weeks after enrollment.

    Perceived Stress Scale-10 (PSS-10) is a 10-item tool to evaluate perception of stress during the past month (Cronbach α: 0.74-0.91). The Perceived Stress Scale (PSS) is a self-assessment tool used to measure stress. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress. Questions are scored 0-4 with scores of 0-13 indicate low; 14-26 indicate moderate; and 27 and above indicate high stress. We will evaluate the PSS of intervention group compared to the change in PSS for the usual care.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Does a Pre-transplant Health Coaching Intervention for Informal Caregivers of Adult Heart or Lung Transplant Candidates Improve Caregiver-Reported Outcomes?

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2020
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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