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

NCT04715490 | Completed

• 1 other identifier: Tri_20200114
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

multimedia; coping strategy; symptom distress; quality of life

Outcome Measures

Primary Outcomes (1)

• Minnesota Living with Heart Failure Questionnaire

  Change from quality of life at 3 months

Secondary Outcomes (3)

• 28-item Brief COPE

  Change from coping strategy at 3 months

• Cardiac Symptom Survey Questionnaire

  Change from symptom distress at 3 months

• Beck Depression Inventory-II

  Change from depressive status at 3 months

Study Arms (2)

The Multimedia Symptom Management Program Intervention

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

The Multimedia Symptom Management Program Intervention OTHER

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.

The Multimedia Symptom Management Program Intervention

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Related Publications (18)

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• 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: 10.1111/jgs.12776. Epub 2014 Mar 21.

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• Feltner C, Jones CD, Cene CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJ, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med. 2014 Jun 3;160(11):774-84. doi: 10.7326/M14-0083.

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• Abbasi A, Najafi Ghezeljeh T, Ashghali Farahani M, Naderi N. Effects of the self-management education program using the multi-method approach and multimedia on the quality of life of patients with chronic heart failure: A non-randomized controlled clinical trial. Contemp Nurse. 2018 Aug-Oct;54(4-5):409-420. doi: 10.1080/10376178.2018.1538705. Epub 2018 Oct 31.

  PMID: 30381006 RESULT

• 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.

  PMID: 30091501 RESULT

• 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(5):377-386. doi: 10.2217/fca-2018-0061. Epub 2019 Sep 10.

  PMID: 31502879 RESULT

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• 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.

  PMID: 29606370 RESULT

• 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 Rehospitalization in Patients with Heart Failure. Int Heart J. 2019 Nov 30;60(6):1293-1302. doi: 10.1536/ihj.19-313. Epub 2019 Nov 15.

  PMID: 31735786 RESULT

• 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. doi: 10.1097/JCN.0000000000000255.

  PMID: 25774836 RESULT

• Oyanguren J, Latorre Garcia PM, Torcal Laguna J, Lekuona Goya I, Rubio Martin 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. Rev Esp Cardiol (Engl Ed). 2016 Oct;69(10):900-914. doi: 10.1016/j.rec.2016.05.012. English, Spanish.

  PMID: 27692124 RESULT

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• 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 Heart J. 1992 Oct;124(4):1017-25. doi: 10.1016/0002-8703(92)90986-6.

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• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

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MeSH Terms

Conditions

Heart Failure

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Chi-Wen Kao, PHD

  Taiwan Nurses Association

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Obstetrics and Gynecology, Clinical Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: May 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: April 1, 2013
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share