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Trial registered on ANZCTR


Registration number
ACTRN12616000210471
Ethics application status
Approved
Date submitted
20/11/2015
Date registered
16/02/2016
Date last updated
8/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Self-Efficacy Enhancing Program on Foot Self-Care Behaviour of Elderly with Diabetes in Old Folks Home, Peninsular Malaysia
Scientific title
Effects of Self-Efficacy Enhancing Program on Foot Self-Care Behaviour of Elderly with Diabetes
Secondary ID [1] 287682 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 296516 0
Foot self-care behaviour 296926 0
Condition category
Condition code
Public Health 296774 296774 0 0
Health promotion/education
Metabolic and Endocrine 297167 297167 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: Cluster Randomized Trial (CRT), two groups (interventions and controls), single blind
The theoretical background of the education program is based from Albert Bandura’s Self-efficacy theory.
The intervention is in a group seminar of education regarding foot care (8-10 respondents/ group/ session)
The program encompasses of 20 minutes of a power point presentation covered the following topics: awareness of risk factors and its complications, foot self-care behavior including daily washing, inspecting foot for problems, moisturizing, wearing proper shoes and socks; toenail and feet care; and when to seek help from a healthcare professional.
At the end of seminar, the researcher will encourage active role and leave the respondents to perform foot self-care behavior independently. A pamphlet regarding foot care will be given to the respondents.
The local nurses (research enumerator) will receive a checklist reminder of foot self-care to continuously support the respondents to perform the behaviour.
Respondents will be encouraged to establish realistic goals on new targets (tailored action plan) in performing foot self-care behaviour. They need to start work in small realistic steps so that they will be more focus, confidence and become motivated to perform the desired behaviour (mastery experience). Respondents will be given a hand-out (symbolic modelling) so that they will perform the foot self-care behaviour daily. In order to maintain their confidence level, a positive feedback and strong encouragement need to be given continuously (verbal persuasion). During follow-up visit (at week 4), the researcher (registered nurse) will discuss (one to one) with respondents, sharing experience and get feedback on goals, examination of obstacles and problem situations (self-appraisal).
A routine visit to the respondents will be done weekly (to monitor adherence) till the end of the program (week-12).
Frequency and duration of administration: The program will be carried out for 12 weeks and consisted of a total of 4 visits: 1) Baseline information (20 minutes), 2) the program (within 4 weeks after baseline information for selected clusters) (week 0; 20 minutes), 3) Follow-up (week 4; 20 minutes for one to one discussion and 20 minutes for answering the questionnaire) and 4) evaluation (week 12; 20 minutes for answering the questionnaire).
Intervention code [1] 293075 0
Behaviour
Comparator / control treatment
The control group (approximately 3 clusters/old folks home) will receive a usual health care.
Usual health care in this study is defined by a routine health care for diabetic patients received from the local health care provider in the old folks home
After completion the program, the control group will receive the same program as the intervention group (waiting list) after 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 296383 0
Foot self-care behaviour, assessed using a modified version of the Diabetes Foot Self-Care Behaviour Scale (DFSBS) (Chin & Huang, 2013)
Timepoint [1] 296383 0
Baseline, and at 4 and 12 weeks after intervention commencement
Secondary outcome [1] 318304 0
Foot care efficacy expectation, assessed using a modified version of the Foot Care Confidence Scale (FCCS) (Sloan, 1998)
Timepoint [1] 318304 0
Baseline, and at 4 and 12 weeks after intervention commencement
Secondary outcome [2] 319320 0
The foot care outcome expectation (FCOE). The score was designed specifically for this study
Timepoint [2] 319320 0
Baseline, and at 4 and 12 weeks after intervention commencement
Secondary outcome [3] 319321 0
The knowledge on foot care (KFC). The score was designed specifically for this study
Timepoint [3] 319321 0
Baseline, and at 4 and 12 weeks after intervention commencement
Secondary outcome [4] 319322 0
Quality of Life, assessed using a modified version of the Neuropathy and Foot Ulcer Specific Quality of Life (FS-QOL) (Vileikyte et al., 2003)
Timepoint [4] 319322 0
Baseline, and at 4 and 12 weeks after intervention commencement
Secondary outcome [5] 319875 0
Foot condition, assessed using a modified version of the foot score (Baba et al, 2015)
Timepoint [5] 319875 0
At baseline and at 12 weeks after intervention commencement
Secondary outcome [6] 330026 0
Program acceptability, assessed using a modified version of the Abbreviated Acceptability Rating Profile (AARP) (Tarnowski & Simonian, 1992)
Timepoint [6] 330026 0
12 weeks after intervention commencement

Eligibility
Key inclusion criteria
The respondent:
1) aged 60 years or more
2) have been diagnosed with diabetes (old or new)
3) presented with or without diabetic foot problems
4) Malaysian.
5) able to communicate sufficiently well (English or Malay) to understand the education program.
6) able to perform activity daily living independently (e.g., bathing, feeding, grooming etc.).
7) have no major complications which would interfere with foot self-care behaviour (such as blind, mute and deaf and stroke).
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Respondents who are currently has been diagnosed with mental health problems (psychotic/ unstable conditions)
2) Respondents who are having impaired in cognitive level.
3) Respondents who are having depression.

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)
Allocation process will be concealed by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using "lottery/ fish-bowl" technique
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7248 0
Malaysia
State/province [1] 7248 0

Funding & Sponsors
Funding source category [1] 292234 0
University
Name [1] 292234 0
Universiti Putra Malaysia
Address [1] 292234 0
Research Management Centre
Universiti Putra Malaysia
43400, Serdang, Selangor
Malaysia
Country [1] 292234 0
Malaysia
Primary sponsor type
Individual
Name
Associate Prof Dr Hejar Abdul Rahman
Address
Community Health Department
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
43400, Serdang, Selangor
Malaysia
Country
Malaysia
Secondary sponsor category [1] 291118 0
None
Name [1] 291118 0
Address [1] 291118 0
Country [1] 291118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293889 0
Ethic Committee for Research Involving Human Subjects (Universiti Putra Malaysia)
Ethics committee address [1] 293889 0
Ethic Committee for Research Involving Human Subjects,
Universiti Putra Malaysia, 43400 UPM Serdang,
Selangor, MALAYSIA
Ethics committee country [1] 293889 0
Malaysia
Date submitted for ethics approval [1] 293889 0
02/07/2015
Approval date [1] 293889 0
10/08/2015
Ethics approval number [1] 293889 0
FPSK(FR15)P021
Ethics committee name [2] 293890 0
Department of Social Welfare
Ethics committee address [2] 293890 0
Department of Social Welfare
Aras 6, 9-18, No 55 Persiaran Perdana
Presint 4, 62100, Putrajaya, Malaysia
Ethics committee country [2] 293890 0
Malaysia
Date submitted for ethics approval [2] 293890 0
15/10/2015
Approval date [2] 293890 0
12/11/2015
Ethics approval number [2] 293890 0
JKMM 100/12/5/2: 2015 / 003

Summary
Brief summary
A cluster randomized trial; two arms (intervention and control), single-blind study will be carried out. The intervention group will receive a self-efficacy enhancing program on foot self-care behaviour while the control group will receive a usual health care.
The aim of the program is, the improvement on foot self-care behaviour (primary outcome), foot efficacy expectation, foot outcome expectation, knowledge on foot care, quality of life and the foot score (secondary outcome) after completion of the program.
The control group will receive the same intervention program at the end of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61010 0
Ms Siti Khuzaimah Ahmad Sharoni
Address 61010 0
Nursing Department,
Faculty of Health Sciences,
Universiti Teknologi MARA
Puncak Alam Campus,
42300, Puncak Alam,
Selangor, Malaysia
Country 61010 0
Malaysia
Phone 61010 0
+60192119284
Fax 61010 0
Email 61010 0
sitik123@yahoo.com
Contact person for public queries
Name 61011 0
A/Prof Dr Hejar Abdul Rahman
Address 61011 0
Community Health Department,
Faculty of Medicine and Health Sciences,
43400, Universiti Putra Malaysia,
Serdang, Malaysia
Country 61011 0
Malaysia
Phone 61011 0
+6012-2362351
Fax 61011 0
Email 61011 0
hejar@upm.edu.my
Contact person for scientific queries
Name 61012 0
A/Prof Dr Hejar Abdul Rahman
Address 61012 0
Community Health Department,
Faculty of Medicine and Health Sciences,
43400, Universiti Putra Malaysia,
Serdang, Malaysia
Country 61012 0
Malaysia
Phone 61012 0
+60122362351
Fax 61012 0
Email 61012 0
hejar@upm.edu.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary