Clinical trial NCT04715490: Effects of a Multimedia Symptom Management Program on Quality of Life in Patients With Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: multimedia
coping strategy
symptom distress
quality of life
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: Change from quality of life at 3 months
Secondary outcomes:
measure: 28-item Brief COPE
timeFrame: Change from coping strategy at 3 months
measure: Cardiac Symptom Survey Questionnaire
timeFrame: Change from symptom distress at 3 months
measure: Beck Depression Inventory-II
timeFrame: Change from depressive status at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Taiwan Nurses Association
name: Chi-Wen Kao, PHD
role: STUDY_DIRECTOR
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