Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000079943
Ethics application status
Not yet submitted
Date submitted
16/01/2011
Date registered
21/01/2011
Date last updated
21/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Hope-inspiring (fostering) Nursing Intervention for Improving the Quality of Life in Chinese Heart failure patients in Hong Kong
Scientific title
Hope-fostering nursing intervention for improving quality of life among Chinese patients with heart failure
Secondary ID [1] 253405 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 260958 0
Condition category
Condition code
Cardiovascular 259093 259093 0 0
Other cardiovascular diseases
Public Health 259147 259147 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experiment group: Hope Fostering intervention

Patients attend 2 x 1.5 hour education sessions per week for 2 weeks plus a 1 hour booster session after 3 months.

Sessions are delivered to maximum 10 people by nurse at the hospital.

The education sessions will contain the education element, supporting group element, and coping skills through knowledge delivery for reinforcing self-esteem, perceived self-efficacy, self-care behaviour, spiritual and religious belief, social support as well as Tai Chi exercise.
Intervention code [1] 257856 0
Lifestyle
Intervention code [2] 257858 0
Rehabilitation
Comparator / control treatment
There are two types of control groups. One is attention-control group and the other is control group.

Attention-control group: Tai Chi program
Patients attend 1 x 1.5 hour Tai Chi program for only one session plus a 1 hour booster session at 3 months.
Sessions are delivered to maximum 10 people by Tai Chi trained nurse at the hospital.

Control group: Usual care
Patients do not need to receive any interventions but just receive routine medical follow-up.
Control group
Active

Outcomes
Primary outcome [1] 261947 0
Level of hope (Herth Hope Index score > 30)
The Herth Hope Index (Herth, 1992) comprises 12 items designed as individual measure multidimensional of hope. Participants are asked to rate each item on a 4-point Likert scale, and are scored from 1 to 4 (1 = strong disagree, 2 = disagree, 3 = agree, 4 = strong agree); total possible scores thus range from 12 to 48, with higher scores indicating greater hopefulness.
Timepoint [1] 261947 0
Baseline, the last day of intervention, 3 month after booster intervention and 6 month after discharge from hospital.
Secondary outcome [1] 268859 0
Self-esteem (The Rosenberg's Self-Esteem Scale (RSES))
The Rosenberg's Self-Esteem Scale (RSES) (Rosenberg, 1965) was designed to measure self-esteem as a global disposition. The RSES consists of 10 items, an example being "I am able to do things as well as most other people. Responses are rated using a 4-poing Likert scale ranging from 1 (strong disagree) to 4 (strongly agree), with total possible scores ranging 10 to 40. Higher scores indicate higher levels of self-esteem.
Timepoint [1] 268859 0
Baseline, the last day of intervention, 3 month after booster intervention and 6 month after discharge from hospital.
Secondary outcome [2] 268860 0
Quality of Life (Short-Form 36 (SF-36))
The Chinese (Hong Kong) version of the Short-Form SF-36 developed by Lam et al (2002) is a 36 item scale widely used to measure the quality of life. It measures 8 area of perceived health: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, with scale-range 0-100 (100 = highest perceived health). It is appropriate to use on different age, diseases or treatment group.
Timepoint [2] 268860 0
Baseline, the last day of intervention, 3 month after booster intervention and 6 month after discharge from hospital.
Secondary outcome [3] 268929 0
Depressive symptoms (Centre for Epidemiologic Studies Depression Scale (CES-D).
The CES-D consists of 20 items, which was originally designed to measure depressive symptoms in general population surveys (Radloff, 1997) and has been used widely with adolescents (Roberts, Andrews, Lewinson, & Hopes, 1990). The CES-D consists of 20 items; an example ofthe items on the scale is 'I had trouble keeping my mind on what I was doing'. Subjects were asked to rate the frequency of each symptoms during the past week on a four-point Likert scale representing 'rately (less than 1 day)', some (1-2 days)', occasionally (3-4 days)' and 'most (5-7 days)', which were scored from 0 to 3, with total possible scores ranging from 0 to 60. Higher scores indicate a greater an individual demonstrating some depressive symptoms.
Timepoint [3] 268929 0
Baseline, the last day of intervention, 3 month after booster intervention and 6 month after discharge from hospital.

Eligibility
Key inclusion criteria
Participants btween the ages of 60 and 70 years with a medical diagnosis of confirmed heart failure greater than 3 years by ward medical record review
man or woman
able to speak Cantonese and read Chinese
Classified as grade II to IV according to the New York Heart Association Classification
heart failure patient's Herth Hope Index score less than 30 regarded as low level of hope
Minimum age
60 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychiatric problems identified in their medical records and also identified patients by interview with Schedule for Affective Disorders and Schizophrenia Lifetime version for ruled out any hidden affective disorders or schizophrenia patients.
impaired cognitive function identified by Mini-Mental Status Examination (MMSE less than 30 were also excluded
family history of heart disease were also excluded
suffered from a coexisting, severe, chronic debilitating disease were excluded
history of known any form of Tai Chi exercise

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Three sealed opaque envelopes will be put in a box. One envelope will be labelled an experiment group, one envelope will be labelled an attention-control group and the envelope will be labelled a control group. A nurse who is blindly about this research and will be asked to draw one envelope from the box to determine group assignment. Another two sealed opaque envelopes with the same group assignment being drawn were then put back in the box again before the next assignment. All participants are eligible for inclusion in the trial were unaware, when this decision is made, to which group the participants will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the sequence is using simple randomisation by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The researcher will choose an experimental design in which the eligible participants will be randomly allocated to three different groups after the pretest baseline measurements are taken as follows:
The experiment group will be exposed to hope-fostering intervention to increase their level of hope.
The attention-control group will participate in the Tai Chi exercise program only and be served as an attention-control purpose.
The last group will be the control group, whose members will be not exposed to any form of intervention apart from the usual care.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
195
Accrual to date
Final
Recruitment outside Australia
Country [1] 3137 0
Hong Kong
State/province [1] 3137 0

Funding & Sponsors
Funding source category [1] 258326 0
Self funded/Unfunded
Name [1] 258326 0
Country [1] 258326 0
Primary sponsor type
Individual
Name
Keung sum CHAN
Address
Flat A., 6/F., Block 11, Park Island, Ma Wan, NT Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 257485 0
None
Name [1] 257485 0
Address [1] 257485 0
Country [1] 257485 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260304 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 260304 0
John Curtin School of Medical Research Building 54, Australian National University, Canberra ACT 0200, Australia
Ethics committee country [1] 260304 0
Australia
Date submitted for ethics approval [1] 260304 0
15/01/2011
Approval date [1] 260304 0
Ethics approval number [1] 260304 0

Summary
Brief summary
The primary purpose of the study is to evaluate the effectiveness, feasibility, and acceptability of the hope-fostering nursing intervention in promoting the quality of life of Chinese heart failure patients in Hong Kong.

The null hypotheses are as follows:
1) There are no statistically significant differences in the level of hope scores, depressive symptom scores, quality of life scores, the level of self-esteem scores in Hong Kong Chinese heart failure patients who receive routine medical follow-up, and participate in the hope-fostering intervention in comparison to those who just receive Tai Chi program and to those who recieve routine medical follow-up with informative pamphlets, and continuing monitoring after discharge from hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32087 0
Address 32087 0
Country 32087 0
Phone 32087 0
Fax 32087 0
Email 32087 0
Contact person for public queries
Name 15334 0
KEUNG SUM CHAN
Address 15334 0
130 Hip Wo Street, 2/F., F Block, Nursing school, United Christian Hospital, Kwun Tong, Hong Kong
Country 15334 0
Hong Kong
Phone 15334 0
+85235133613
Fax 15334 0
+85235135683
Email 15334 0
[email protected]
Contact person for scientific queries
Name 6262 0
KEUNG SUM CHAN
Address 6262 0
130 Hip Wo Street, 2/F., F Block, Nursing school, United Christian Hospital, Kwun Tong, Hong Kong
Country 6262 0
Hong Kong
Phone 6262 0
+85235133613
Fax 6262 0
+85235135683
Email 6262 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.