A Trial of an Online Mindfulness Based Programme for Informal Caregivers

Status Terminated

Clinical Trial Summary

This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses

Clinical Trial Description

The primary aim of the project is to pilot test the delivery of an online Mindfulness Based Stress Reduction (MBSR) programme to informal caregivers of people with chronic illnesses in one region in Ireland so as to determine the feasibility of delivering the intervention to caregivers in Ireland.

A two-group randomised pilot-feasibility trial comparing the online MBSR programme (intervention) with no programme (control). The MBSR programme is delivered online over 8 weeks. Weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. The study sample are caregivers in the Dublin region who are members of Family Carers' Ireland. A total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator.

Baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and QoL) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. Other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. Feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. Mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and QoL. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03048565
Study type	Interventional
Source	University of Dublin, Trinity College
Contact
Status	Terminated
Phase	N/A
Start date	September 13, 2017
Completion date	October 4, 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05785494` - Web-based Support for Family Caregivers of Patients With Advanced Cancer	N/A
Completed	`NCT03601884` - Effectiveness of OHP in Improving Self-efficacy in Patients With Diabetes Mellitus	N/A
Recruiting	`NCT03170167` - Communitas: A Program for Teens Living With Chronic Illness and Their Families
Completed	`NCT01955005` - Use of the My HealtheVet for Health Information Sharing	N/A
Completed	`NCT01107119` - Integrated Care Pathways in a Community Setting	N/A
Completed	`NCT00194584` - Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs	N/A
Completed	`NCT03434626` - Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care	N/A
Recruiting	`NCT05437978` - "Sport on Prescription" in Primary Care for Patients With Long-term Illnesses	N/A
Completed	`NCT03067207` - In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness	N/A
Completed	`NCT02277327` - Trial to Reduce Hospitalizations in Children With Medical Complexity	Phase 2
Recruiting	`NCT01480765` - Preventing Pain After Heart Surgery	Phase 4
Completed	`NCT01834456` - Comprehensive Care of Children With Medical Complexity	N/A
Completed	`NCT00773942` - Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries	N/A
Terminated	`NCT00399373` - Structuring the Integration of Care Management Services For Medicaid Enrollees Recipients With Chronic Illness, Substance Abuse Problems and Possible Psychiatric Disorders	N/A
Completed	`NCT02925897` - Enhancing Self-care in the Housebound	N/A
Completed	`NCT01321853` - Home Care Medication Management Program for the Frail Elderly	Phase 1
Completed	`NCT03295097` - Characteristics and Clinical Implications of a Clinical Decision Support System	N/A
Suspended	`NCT04978610` - Virtual ACT for Adolescent Stress	N/A
Completed	`NCT01797068` - Patient Navigation for Medicaid Frequent ED Users	N/A
Completed	`NCT02386189` - Pilot Study to Improve Care Coordination	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms