Effects of a Multimedia Symptom Management Program on Quality of Life in Patients With Heart Failure

January 19, 2021 updated by: Fung-Wei Chang, Tri-Service General Hospital

Effects of a Multimedia Symptom Management Program on Coping Strategies, Symptom Distress, Depressive Status, and Quality of Life in Patients With Heart Failure: A Randomized Controlled Trial

The aim of this study is to evaluate the effectiveness of a Multimedia Symptom Management Program on increasing coping strategies, reducing symptom distress and depression, and improving HRQoL in patients with HF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design A single-blind two-group longitudinal experimental study will be conducted to compare a Multimedia Symptom Management Program with a usual care.

After receiving informed consents, participants will be randomly assigned to intervention and control groups at a 1:1 ratio. The intervention group will receive a Multimedia Symptom Management Program; the control group will receive usual care. Outcomes from four self-report questionnaires at 1 month and 3 months after initiating the intervention will be compared to baseline assessments. Outcome measurements include the following parameters: 28-item Brief COPE, Cardiac Symptom Survey (CSS), Beck Depression Inventory-II (BDI-II), and Minnesota Living with Heart Failure Questionnaire (MLHFQ).

Inclusion and exclusion criteria The inclusion criteria are: (1) those who are ≥20 years old and HF diagnosed by a cardiology specialist, (2) have clear consciousness, (3) are fluent in Mandarin/Taiwanese. The exclusion criteria are: (1) diagnosed with any psychiatric disorder, (2) are addicting to drugs or alcohol at the time of the study, (3) are undergoing other psychotherapy during the study and (4) are refusing to participate in the study.

Recruitment Participants will be recruited from a cardiology outpatient clinic of a medical center in northern Taiwan. The study design and protocols had been reviewed and approved by the institutional review board of the participating hospital. At the content session, all assessments and procedures will be fully explained.

Assessment of eligibility and randomisation Participants will be considered eligible if they meet the inclusion criteria. All participants will be informed that they are able to withdraw from the study at any time. Before randomisation, participants will be asked to answer five questionnaires. The questionnaires include demographic characteristics, 28-item Brief COPE, Cardiac Symptom Survey (CSS), Beck Depression Inventory-II (BDI-II), and Minnesota Living with Heart Failure Questionnaire (MLHFQ). Participants will be randomly assigned to either the intervention group or the control group at a 1:1 ratio; randomization will be performed with the use of a computer-generated randomization scheme (SPSS software Version 23.0).

Blinding Participants will be randomly assigned to either the Multimedia Symptom Management Program or medical consultation and usual care. Random assignment will be performed by a person who are not involved in the study. The outcome evaluator will be blinded to the assigned condition of the participants.

Intervention Participants will be randomly assigned to the Multimedia Symptom Management Program Intervention group or the control group using SPSS software (Version 23.0).

The Multimedia Symptom Management Program Intervention The program is composed of two parts: 1) a face-to-face presentation about the contents of the program, and 2) structured telephone support. The first part of the program will be conducted in the cardiology outpatient department. Participants will be instructed to read a HF handbook. In addition, they will also be provided with multimedia symptom management instruction through a live-action feature film on a DVD, which will be designed and produced by the researchers to help familiarize patients with the symptoms and characteristics of HF, how to perform self-evaluations, and ways to manage symptoms of HF. After the conclusion of the face-to-face presentation, we will ensure that participants have fully comprehended all instructions with the return demonstration method, in which participants had reviewed the HF handbook and multimedia symptom management DVD at home and will be encouraged to review management of their symptoms daily.

The second part of the program, structured telephone support, allowed the nurses to maintain contact with the participants in order to follow their progress. The participants will be scheduled to receive eight telephone coaching calls over a 3-month period. In the first month, participants will receive telephone coaching calls every week. Through the phone calls, the nurse clinician will try to sustain the participants' symptom management knowledge and skills by encouraging them to discuss what they had learned from the DVD to discuss how they had managed their symptoms. Subsequent telephone counselling calls will be conducted every 2 weeks in the second and third months to follow their situations and assist them in dealing with any health problems.

Control group Participants in the control group will be provided with the HF handbook at the beginning of the 3-month period, and also will be received usual care, which included medical consultations, and two telephone calls.

Outcomes measurements Primary outcome Health-related quality of life (HRQoL): The 21-item Minnesota Living with Heart Failure Questionnaire (MLHFQ) is used to measure HRQoL in adult patients with HF. A 6-point Likert scale is used to score the impact on HRQoL from 0 = "No effect" to 5 = "Severe effect". Total scores range from 0 to 105, with higher scores indicating a worse HRQoL. The Cronbach's alpha coefficient of MLHFQ was 0.92.

Secondary outcome Brief COPE: The 28-item Brief COPE self-report questionnaire measure strategies participants use for coping. The Brief-COPE is divided into approach coping, in which individuals actively seek resources to deal with their health problems; and avoidance coping, in which individuals attempt to divert attention away from events. Higher scores indicate greater use of the specific coping strategy.

Cardiac Symptom Survey (CSS): CSS is originally used as a tool to assess symptoms of patients undergoing coronary artery bypass surgery, assessed symptom distress. In this study, we only assessed only the 20 items for frequency and severity of symptoms. We obtained permission from Dr. L. J. Nieveen to change the wording of one item, "surgery pain", to "activity intolerance".

Beck Depression Inventory-II (BDI-II): BDI-II is used to measure the depressive status of participants. The self-report questionnaire asks about symptoms of depression over a 2-week period. Higher total scores indicating a more severe of depressive status: 0-13 = normal; 14-29 = mild; 28-28 = moderate; and 29-63 = severe depressive status.

Statistical analysis We will use descriptive statistics (mean, standard deviation, frequency and percentage) to analyse participant characteristics and primary outcomes. The initial differences between groups for demographic characteristics, symptom distress, coping strategies, depressive status, and HRQoL will be examined with independent t-tests and Chi-square analysis. Effects of the Multimedia Symptom Management Program on symptom distress, coping strategies, depressive status and HRQoL in patients with HF will be analysed using generalized estimating equations (GEE). The significance will be defined as a two-tailed P-value of < 0.05.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. those who are ≥20 years old and HF diagnosed by a cardiology specialist
  2. have clear consciousness
  3. are fluent in Mandarin/Taiwanese.

Exclusion Criteria:

  1. diagnosed with any psychiatric disorder
  2. are addicting to drugs or alcohol at the time of the study
  3. are undergoing other clinical trial during the study
  4. are refusing to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The Multimedia Symptom Management Program Intervention
The program is composed of two parts: 1) a face-to-face presentation about the contents of the program, and 2) structured telephone support.
Other: The Multimedia Symptom Management Program Intervention

The program is composed of two parts: 1) a face-to-face presentation about the contents of the program, and 2) structured telephone support. The first part of the program will be conducted in the cardiology outpatient department. Participants will be instructed to read a HF handbook.

The second part of the program, structured telephone support, allowed the nurses to maintain contact with the participants in order to follow their progress. The participants will be scheduled to receive eight telephone coaching calls over a 3-month period.
ACTIVE_COMPARATOR: Control group
Participants in the control group will be provided with the HF handbook at the beginning of the 3-month period, and also will be received usual care, which included medical consultations, and two telephone calls.
Other: Control group
The control group will be provided with the HF handbook at the beginning of the 3-month period, and also will be received usual care, which included medical consultations, and two telephone calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Minnesota Living with Heart Failure Questionnaire
Time Frame: Change from quality of life at 3 months
Change from quality of life at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
28-item Brief COPE
Time Frame: Change from coping strategy at 3 months
Change from coping strategy at 3 months
Cardiac Symptom Survey Questionnaire
Time Frame: Change from symptom distress at 3 months
Change from symptom distress at 3 months
Beck Depression Inventory-II
Time Frame: Change from depressive status at 3 months
Change from depressive status at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Study Director: Chi-Wen Kao, PHD, Taiwan Nurses Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (ACTUAL)

January 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tri_20200114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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