Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715490
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2021-01-14
Brief Title:
Effects of a Multimedia Symptom Management Program on Quality of Life in Patients With Heart Failure
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 MandarinTaiwanese 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 11 ratio randomization will be performed with the use of a computer-generated randomization scheme SPSS software Version 230
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 230
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 Cronbachs alpha coefficient of MLHFQ was 092
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 005
After receiving informed consents participants will be randomly assigned to intervention and control groups at a 11 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 MandarinTaiwanese 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 11 ratio randomization will be performed with the use of a computer-generated randomization scheme SPSS software Version 230
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 230
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 Cronbachs alpha coefficient of MLHFQ was 092
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None