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Evaluation of an E-intervention on MHBC for Chinese Cardiac Patients in Home-based Rehabilitation

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ClinicalTrials.gov Identifier: NCT03636724
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Yanping DUAN, Hong Kong Baptist University

Brief Summary:
By using the Health Action Process Approach (HAPA) model as a theoretical backdrop, the proposed study aims to provide an 8-week e-health learning strategies for Chinese cardiac patients, with which they can follow at home after rehabilitation discharge. The current study will examine whether the cardiac rehabilitation patients in intervention group would increase their physical activity (PA) level and fruit-vegetable intake (FVI), improve the social-cognitive variables of PA and FVI, and enhance mental health outcomes in comparison with control condition; and whether the social-cognitive variables would mediate the association between intervention and adopting a healthy lifestyle. The study findings may contribute to the current multiple health behaviour intervention research and support Chinese cardiac patients to maintain rehabilitation outcomes and cultivate a healthy lifestyle.

Condition or disease Intervention/treatment Phase
Cardiac Rehabilitation Physical Activity Fruit and Vegetable Intake Behavioral: E-intervention Not Applicable

Detailed Description:

For the main study, the sample size will be estimated by using G*Power 3.1 software with MANOVA of repeated measures approach. For achieving a medium effect size of 0.25 (Duan et al., 2017), with a power (1-β) of 0.8 and an alpha of 0.05, the total sample size will be 116. Assuming a dropout rate of approximately 30%, a total of 166 participants will be required for the study evaluation.

All data will be analyzed by using SPSS 23.0 software. Independent samples t-tests and Chi2-tests will be adopted to examine the characteristics of drop out and compare the differences of baseline data at T1. Statistical significance will be set at 5% level (two-tailed). The intervention effects on behavioural, social-cognitive and mental health status-related indicators will be tested by conducting the multivariate analysis of variance (MANOVA) with repeated measures, with time (T1, T2 and T3) as the with-in subjects factor and group (IG and CG) as the between-subjects factor. Missing data will be imputed within each measurement point in time using the Expectation-Maximization (EM) method. Furthermore, the intervention effect on healthy lifestyle indicator will be examined by performing a multinomial logistic regression model. The multiple-mediator model will be conducted to test the mediation effects with the use of SPSS macro (Preacher & Hayes, 2008).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of an E-intervention on Multiple Health Behaviour Change for Chinese Cardiac Patients in Home-based Rehabilitation
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention group
Patients will receive the interventions on both PA and FVI simultaneously.
Behavioral: E-intervention
The 8-week e-health intervention will target HAPA-based social-cognitive variables of PA and FVI. Particularly, Week 1: risk perception and outcome expectancies; Week 2: goal setting; Week 3: development of action plans; Week 4: revision and adjustment of previous action plans; Week 5: development of coping plans; Week 6: revision and adjustment of previous coping plans; Week 7: development of perceived social support; Week 8: revision and adjustment of previous social support. Self-efficacy will be a fixed intervention variable involved from week 2 to week 8. Additionally, some behaviour change techniques will be employed in the intervention in order to facilitate the implementation and maintenance of behaviour.

No Intervention: Waiting control group
Patients will not receive any supportive interventions on PA or FVI during the intervention period but will be provided with the same intervention at follow-up six-month after the intervention.



Primary Outcome Measures :
  1. Change of weekly amount of physical activity (PA) [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    The level of PA will be measured through the short Chinese version of the International Physical Activity Questionnaire (IPAQ-C) questionnaire. Participants will be asked to estimate the number of days and hours spent for vigorous, moderate and walking activities during the past week. The total physical activity score for each participants is the sum of frequency per week, multiplied by time-consumption (minutes) each time.

  2. Change of daily portions of fruit-vegetable intake (FVI) [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    Fruit and vegetable intake (FVI) will be measured with four items, including fruit or vegetable juice, fruit, cooked or steamed vegetables, and raw vegetables. Respondents will be asked to count the number of portions of fruit and vegetables they consumed on average during a typical day. Each item has 11 options for the number of portions such as 0, 0.5, 1, 1.5, 2, 2.5, ..., and 5 or above. The total portion of fruit and vegetable consumption is the sum of each item.


Secondary Outcome Measures :
  1. Change of self-efficacy of PA and FVI [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    Self-efficacy will be assessed with three dimensions consisting of motivational, maintenance and recovery self-efficacies with the stem "I am certain that…" followed by 5 items for PA such as "…I can be physically active permanently at a minimum of 5 days a week for 30 minutes even if it is difficult", or followed by 5 items for FVI such as "…I can eat 5 portions of fruit and vegetable a day even if it is difficult." Answers will be given on a 5-point Likert scale, ranging from don't agree at all "1" to agree completely "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of self-efficacy.

  2. Change of intention of PA and FVI [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    The intention for PA will be assessed with the stem "I intend to do for at least 30 minutes a day on minimum 5 days a week or at least 150 minutes a week with…" followed by 3 items such as "… vigorous sport", "…moderate PA" and "…mild PA". The intention for FVI will be measured by the stem " I seriously intend to..." followed by 3 items such as "eat at least 5 servings of fruit and vegetable each day" and "… drink each day at least one glass of fruit or vegetable juice". Answers will be given on a 4-point Likert scale, ranging from not true "1" to exactly true "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of intention.

  3. Change of planning of PA and FVI [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    Planning indicator will be assessed with 6 items, consisting of action planning and coping planning with 3 items for each dimension. The item of action planning for PA will be asked such as "…which concreted PA I will pursue", for FVI such as "…how I will prepare the food". The items of coping planning for PA will be asked such as "…how I can stay active, even if something happened", for FVI such as "what I can do in difficult situations, in order to remain true to my own resolutions". Answers will be given on a 5-point Likert scale, ranging from totally disagree "1" to totally agree "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of planning.

  4. Change of perceived social support of PA and FVI [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    For the perceived social support, the scale will be measured with the stem as "How do you perceived your environment?" followed by 3 items for PA such as"….People like my friends help me to stay physically active", or followed by 3 items for FVI such as "…People like my friends help me to eat healthily". Answers will be given on a 4-point Likert scale, ranging from totally disagree "1" to totally agree "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of perceived social support.

  5. Change of perceived quality of life: WHO Quality of Life-BREF [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    This indicator will be assessed by using the short version of the World Health Organisation Quality of Life (WHOQOL-BREF). Respondents will be first asked about their general quality of life as "How would you rate your quality of life?", then 7 items in physical health sub-domain will be used, such as the example item "To what extent do you feel that physical pain prevents you from doing what you need to do?". Answers will be given on a 5-point Likert scale, ranging from very poor "1" to very good "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of perceived quality of life.

  6. Change of depression [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    Level of depression will be assessed with the use of the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Respondents will be asked with the stem as "In the past week how often I feel …" followed by 10 items such as "…I was bothered by things that usually don't bother me". Answers will be given on a 4-point Likert scale, ranging from rarely or none of the time (less than 1 day) "0" to most or all of the time (5-7 days) "3". The mean value of the total score will be calculated and the higher score denotes to the higher level of depression.

  7. Change of body mass index (BMI) [ Time Frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up ]
    Participants will be asked to report their body height (in m) and body weight (in kg) for calculating the BMI, using the equation "BMI=weight/ height square".


Other Outcome Measures:
  1. Social-demographic information [ Time Frame: At the beginning of intervention (Baseline) ]
    The items consist of gender, age, marital status, education level, rehabilitation treatment history, and current work status.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no restriction of physical mobility under the cardiac function at entry
  • no restriction of relevant diseases such as diabetes or fruit allergies
  • As the study involves an online website and mobile phone SMS, only participants with access to the Internet via mobile phone will be enrolled

Exclusion Criteria:

  • have restrictions of physical mobility under the cardiac function at entry
  • have restrictions of relevant diseases such as diabetes or fruit allergies
  • cannot use the Internet and mobile phone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636724


Contacts
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Contact: Yanping Duan (852)6223-2742 duanyp@hkbu.edu.hk

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Lan Guo    13922130326    guolan1993@126.com   
Sub-Investigator: Lan Guo         
Sponsors and Collaborators
Hong Kong Baptist University
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: Yanping Duan Hong Kong Baptist University
  Study Documents (Full-Text)

Documents provided by Yanping DUAN, Hong Kong Baptist University:
Informed Consent Form  [PDF] June 7, 2018


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Responsible Party: Yanping DUAN, Assistant Professor, Dr. Duan, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT03636724     History of Changes
Other Study ID Numbers: FRG2/17-18/099
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanping DUAN, Hong Kong Baptist University:
E-health intervention
multiple health behavior change
Health Action Process Approach Model
Cardiac patients