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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715490
• Other study ID #: Tri_20200114
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2021
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

References & Publications (18)

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Gagné M, Legault C, Boulet LP, Charbonneau L, Lemyre M, Giguere AMC, Poirier P. Impact of adding a video to patient education on quality of life among adults with atrial fibrillation: a randomized controlled trial. Patient Educ Couns. 2019 Aug;102(8):1490 — View Citation

Gellis ZD, Kenaley BL, Ten Have T. Integrated telehealth care for chronic illness and depression in geriatric home care patients: the Integrated Telehealth Education and Activation of Mood (I-TEAM) study. J Am Geriatr Soc. 2014 May;62(5):889-95. doi: 10.1 — View Citation

Li CC, Chang SR, Shun SC. The self-care coping process in patients with chronic heart failure: A qualitative study. J Clin Nurs. 2019 Feb;28(3-4):509-519. doi: 10.1111/jocn.14640. Epub 2018 Aug 28. — View Citation

Li CC, Shun SC. Understanding self care coping styles in patients with chronic heart failure: A systematic review. Eur J Cardiovasc Nurs. 2016 Feb;15(1):12-9. doi: 10.1177/1474515115572046. Epub 2015 Feb 13. Review. — View Citation

Malik AH, Malik SS, Aronow WS; MAGIC (Meta-analysis And oriGinal Investigation in Cardiology) investigators. Effect of home-based follow-up intervention on readmissions and mortality in heart failure patients: a meta-analysis. Future Cardiol. 2019 Sep;15( — View Citation

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Mizukawa M, Moriyama M, Yamamoto H, Rahman MM, Naka M, Kitagawa T, Kobayashi S, Oda N, Yasunobu Y, Tomiyama M, Morishima N, Matsuda K, Kihara Y. Nurse-Led Collaborative Management Using Telemonitoring Improves Quality of Life and Prevention of Rehospitali — View Citation

Nes LS, Segerstrom SC. Dispositional optimism and coping: a meta-analytic review. Pers Soc Psychol Rev. 2006;10(3):235-51. — View Citation

Nieveen JL, Zimmerman LM, Barnason SA, Yates BC. Development and content validity testing of the Cardiac Symptom Survey in patients after coronary artery bypass grafting. Heart Lung. 2008 Jan-Feb;37(1):17-27. doi: 10.1016/j.hrtlng.2006.12.002. — View Citation

Oyanguren J, Latorre García PM, Torcal Laguna J, Lekuona Goya I, Rubio Martín S, Maull Lafuente E, Grandes G. Effectiveness and Factors Determining the Success of Management Programs for Patients With Heart Failure: A Systematic Review and Meta-analysis. — View Citation

Piamjariyakul U, Thompson NC, Russell C, Smith CE. The effect of nurse-led group discussions by race on depressive symptoms in patients with heart failure. Heart Lung. 2018 May - Jun;47(3):211-215. doi: 10.1016/j.hrtlng.2018.02.005. Epub 2018 Mar 30. — View Citation

Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Hea — View Citation

Smith CE, Piamjariyakul U, Dalton KM, Russell C, Wick J, Ellerbeck EF. Nurse-Led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials, and Outcomes Used in the Clinical Trial. J Cardiovasc Nurs. 2015 Jul-Aug;30(4 Suppl 1):S25-34. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minnesota Living with Heart Failure Questionnaire		Change from quality of life at 3 months
Secondary	28-item Brief COPE		Change from coping strategy at 3 months
Secondary	Cardiac Symptom Survey Questionnaire		Change from symptom distress at 3 months
Secondary	Beck Depression Inventory-II		Change from depressive status at 3 months