Feasibility and Acceptability of a Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
Phase: NA
Conditions: Foot Ulcer
Sponsor: National Healthcare Group Polyclinics

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Feasibility and acceptability of a personalised self-care support 
program for primary care patients with diabetic foot ulcer delivered 
by wound care nurses: the HEALing study protocol 
 
 
 
NCT06540170  
10 Aug 2024 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Introduction  
Diabetic foot ulcers (DFU) are highly prevalent and recurrent complications of diabetes 
mellitus (DM) that have significant health and cost implications. Self-care is critical for 
preventing or delaying DFU yet adherence to self-care recommendation is low. 
Interventions using motivational interviewing (MI) have been effective in supporting 
behaviour change but evidence for DFU is scarce. This study will assess the 
acceptability, feasibility and preliminary efficacy of an MI-guided program, Healing 
DFU through Empowerment and Active Listening (HEALing), and its integration in 
usual wound care practice.ProtocolP 
 
Methods and analysis 
This single-arm pilot study uses a mixed-method approach to assess the feasibility 
and acceptability of the HEALing intervention. HEALing, a practical, low-intensity, 
clinic-integrated intervention consists of three 30-minute face-to-face sessions of a 
personalised care support over a period of 6 weeks conducted by trained wound care 
nurses seeking to support self-care behaviours and emotional adjustments among 
patients who have DFU. Data will be collected from a battery of questionnaire-based 
surveys with patients (N=30), and with in-depth individual interviews with patients 
(N=30) and wound care nurse facilitators (N=10) from nurse-led wound clinics in a 
large primary care sector in Singapore. 
The primary feasibility outcomes will include enrolment, retention (≥ 80%), data 
completion (≥ 80% of surveys), and participant satisfaction. Secondary outcomes will 
include self-report measures of illness perceptions, self-efficacy, diabetes distress, 
foot self-care, DFU knowledge, autonomy support, and quality of life, taken at baseline 
and 2-4 weeks post completion of HEALing. Exit interviews with patients and wound 
care nurse facilitators will collect feedback on program and its implementation 
feasibility. 
 
Ethics and dissemination  
The study protocol was approved by the local ethics committees and written informed 
consent is required from every participant. The findings will be disseminated through 
various means including peer-reviewed journals, as well as well as national and 
international conferences and public events. 
Trial registration number Prospectively registered; NCT06540170 
 
STRENGTHS AND LIMITATIONS OF THIS STUDY  
 Key strengths include the substantial patient and public involvement in the 
development and implementation of HEALing intervention.  
 Another strength is the mixed-method design, with interview data used to 
complement quantitative survey findings. 

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 The design of a single arm has some limitations, such as being unable to 
compare outcomes between groups. 
 Only short- term outcomes will be evaluated; hence sustainability of effects will 
not be known. 
 
 
 
 
METHODS  
 
Study design  
To determine feasibility and acceptability, a single-arm hybrid effectiveness-
implementation pilot study using a mixed-methods design will be used to collect data 
on recruitment, retention, completion and feedback on program and its implementation 
using in-depth interviews with patients and HCPs involved in the delivery of HEALing 
(see Figure 1 for patient recruitment and study procedures). To determine the 
preliminary effectiveness of HEALing, a single group pre- and post-assessment design 
will be used. Assessments using validated questionnaires listed in Table 1 will be 
taken at baseline and 4 weeks from last session of HEALing intervention. Qualitative 
interviews will be used at the end of the main trial to examine HCPs’ and patients’ 
experiences of delivering and receiving the program at end of the study to identify 
implementation issues in need of refinement. A triangulated mixed method approach 
combining and contrasting perspectives of patients and HCPs will allow for a 
comprehensive scope of the feasibility and acceptability of the programme.  
 
 
Participants 
 
Patient participants 
All patients who have T2DM and DFU aged 21 years or above receiving treatment in 
the eight polyclinics will be eligible and invited to participate in the study over a period 
of six months. Patients are excluded if they: (i) do not have a minimum toe pressure 
of 30mmHg; (ii) have active osteomyelitis; (iii) are diagnosed with Charcot foot; or (IV) 
have cognitive, hearing or vision impairment. A sample size of 25-30 patient 
participants is chosen in accordance with published guidance for pilot studies and 
allowance for dropouts1.  
A study team member will meet with eligible and interested participants to review the 
consent form, answer any questions, and assure the patient that participation is not a 
requisite for concomitant care. Patients with DFU receiving the HEALing program will 
be invited to take part in the quantitative surveys and qualitative interviews.  
 
 
Data collection 
Quantitative data including sociodemographic characteristics, clinical indicators, 
healthcare utilisation data, and patient reported outcome measures (PROM) will be 
collected at baseline upon enrolment and at post HEALing completion (i.e., at week 4 

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from the last/third session of HEALing intervention, or three months from enrolment, 
whichever comes first).  
 
Table 1 Sociodemographic/clinical characteristics and constructs, variables of 
interest, scales and measurement time points for secondary outcomes  
 
Variable/Construct  
Scale  
Baseline 
*HEALing 
completion 
Sociodemographic and clinical characteristics 
Sociodemographic 
characteristics 
Age, ethnicity, gender, highest 
education qualification, living 
arrangement, relationship status, 
employment status, type of dwelling 
x 
 
Clinical characteristics 
(diabetes and diabetic 
foot ulcer) 
Type of diabetes, duration of diabetes, 
diabetes treatment, number of DFU, 
history of DFU, location of DF 
x 
 
Clinical characteristics 
(diabetes and diabetic 
foot ulcer) 
HbA1C, wound size reduction, wound 
exudate level, wound bed appearance, 
peri-wound conditions, DFU related 
hospitalization 
x 
x 
Patient Reported Outcome Measures (PROM)  
 
Autonomy support  
Patients’ perceptions of autonomy 
support2-6 items  
x 
x 
Foot self-care 
behaviour 
Diabetes Foot Self-Care Behaviour 
Scale3 – 7 items  
x 
x 
Illness belief 
Brief Illness Perception Questionnaire4 – 
8 items 
x 
x 
Foot care confidence  
Foot Care Confidence Scale5 – 12 items  x 
x 
Diabetes distress  
Diabetes Distress Scale6– 17 items  
x 
x 
Warning signs of 
wound deterioration  
Warning Signs of Diabetic Foot Ulcer 
Deterioration Questionnaire7 – 12 items  
x 
x 
Health-related quality of 
life 
Health-Related Quality of Life - EQ-5D-
5L8  
x 
x 
*HEALing completion: 2-4 weeks from the last HEALing session, or 3 months from the enrolment, 
whichever first; DFU: diabetic foot ulcer 
 

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Figure 1 Flow diagram of the study designed to assess the feasibility and acceptability of a novel self-care 
support intervention (HEALing). PROM: patient reported outcome measures 
 
The HEALing Intervention  
The HEALing programme was co-designed with patients living with DFU and their 
healthcare providers (i.e., wound care nurses). In brief, the programme involved three 
face-to-face sessions (30 minutes per session) and will be delivered over a 3-6-week 
period (i.e., 1-2 times weekly) by trained wound care nurses who also perform patients’ 
routine wound dressings and conduct regular foot wound education. The HEALing 
session outlines are presented in Table 2. 
Following enrolment, patients with DFU will be scheduled to receive three 30-minute 
face-to-face HEALing sessions typically every 1-2 weeks to coincide with routine care 
appointments (augmented usual care (AUC)). Each session will comprise 30 minutes 
wound dressing (usual care) followed by 30 minutes HEALing session post dressing. 
 
Table 2 HEALing session outlines 
Session and theme 
Outline of session  
Session 1 
Self-management/ self-
care skills, and setting 
goals related to 
treatment (week 1-2) 
Introduce HEALing program; agenda mapping of self-care tasks to 
identify areas of competency and areas in need of improvement; 
provide information/advice with permission using the Ask-Offer-Ask 
framework to support the chosen self-care task; review and issue 
patient education leaflets as appropriate/available for chosen topic of 
session; set a short-term goal using confidence rulers considering its 
benefits, barriers, and importance to practice before the next session. 
 
Session 2 
Managing mood--
acceptance and hope 
[This topic to be 
brought in with 
permission by nurse] 
(week 3-4) 
Invite patient to choose topic (see card sorting task photo); use 
affirmation (see card sorting task) and review of the 1st goal from 
session 1 to evoke and strengthen confidence that progress is 
underway.   
 
If topic on low mood/worry OR suggest topic with permission (e.g. 
low mood/ worry about would deterioration or topic that is deemed of 
high clinical importance e.g. self-wound care) 

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– listen to concerns, use validation and normalization to stabilize 
emotion (e.g. anxiety/worry as expected, adaptive response to a real 
threat; this threat can be mitigated with self-care); with permission 
use Ask-Offer-Ask framework to provide advice related to self-care 
and timely recognition or actions as means to reduce threat and 
adverse DFU outcomes; summary to start with worry is expected 
and normal, and finish with the steps taken or progress made with 
self-care to show that progress is being made). 
 
Offer/Ask feedback and then set a short-term goal using confidence 
rulers considering its benefits, barriers, and importance to practice 
before the next session. 
 
Session 3 
HEALing in Action-
living life beyond foot 
disease (repeat card 
sorting task) (week 5-
6) 
Repeat card sorting task; affirm steps in right direction (even if goal 
is not met or perhaps with partial successes – good intentions) 
review goal *step up or down etc; review goal setting progress and 
problems solve barriers (if any) for goal(s) set in session 1 & 2, and 
revise goals as needed; use Ask-Offer-Ask framework to problem 
solve lapses and barriers; use agenda mapping (as above) to 
address any pending important concerns; provide information/advice 
on chosen topic using the Ask-Offer-Ask framework; goal setting 
(using importance and confidence rulers to tailor goals and 
behaviour); conclude with Ask-Offer-Ask framework to provide 
additional advice and links to available resources as patients 
continue to move forward with their goals. 
 
 
Outcome Measures  
 
Primary outcomes 
The primary outcomes include the feasibility indicators: recruitment (i.e., number 
eligible participants invited over number consented), retention (i.e., 80% complete all 
sessions), data completion (80%), and the acceptability of the intervention. The 
following recruitment metrics will be monitored: recruitment will be monitored using 
participant screening logs including number of people accept the invitation to 
participate in the study, number of people receive the intervention, and number of 
people complete the intervention.  
 
Feasibility of retention will be recorded including number of people complete the 
intervention - retention rates upon HEALing completion, i.e., number of sessions 
delivered/attended/completed by HCPs and patients. Feasibility of measurement tools 
include time taken to conduct the HEALing sessions and fill in questionnaires, as well 
as missing or completion of data capture from questionnaires. 
 
Acceptability of the intervention to patient and HCP participants will be determined by 
semi-structured individual interviews at the end of study focusing on satisfaction and 
perceptions, i.e., barriers, challenges and reasons for not taking part/discontinuation 
or dropping out.  
 
Secondary outcomes  
The secondary outcomes include PROMs that will be assessed using standardized 
English version and psychometrically sound instruments, i.e., illness/DFU perceptions 

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measured by Brief Illness Perception Questionnaire4, diabetes distress measured by 
Diabetes Distress Scale6, foot care confidence measured  by Foot Care Confidence 
Scale5, foot self-care behaviour measured by Diabetes Foot Self-Care Behaviour 
Scale3, knowledge on warning signs of diabetic foot ulcer deterioration measured by 
Warning Signs of Diabetic Foot Ulcer Deterioration Questionnaire7, and quality of life 
measured by EQ-5D-5L8. Various clinical endpoints characteristics (i.e., related to DM 
and DFU) will be assessed at baseline and HEALing completion. Table 1 lists variables 
of interest, scales and measurement time points for secondary outcomes. 
 
 
Data Analysis  
 
Quantitative data analysis  
Data collected will be entered into a secured database for analysis. Statistical analysis 
will be performed using the statistical software SPSS Statistics Version 28. Descriptive 
statistics—median (IQR); mean (SD); number (%)—will be used to analyse the 
numbers of patients recruited and retained, as well as patients’ adherence to the self-
care activities and session attendance. Analysis of the above outcome measures will 
be used to develop an assessment of the feasibility of delivering this intervention.  
 
PROM recorded at baseline will be compared with PROM at HEALing completion to 
determine if the HEALing intervention had an impact on illness beliefs, foot care 
confidence, diabetes distress, knowledge of the warning signs of DFU deterioration, 
quality of life and diabetes foot self-care behaviours. The distribution of each outcome 
measure will be assessed for normality. Differences in PROMs between baseline and 
HEALing completion will be assessed using univariable analyses such as chi-square 
test for categorical variables and independent samples t-test or analysis of variance 
for continuous variables where appropriate. Paired t-test will be used to explore if there 
is a significant difference between the means of pre- and post-PROMs. Non-
parametric (Mann-Whitney U test) statistics will be used for continuous variables if the 
data is skewed. Statistical significance (two-tailed) will be set at p<.05.  
 
Qualitative data analysis 
The audio-recorded interviews will be transcribed verbatim and analysed using 
reflexive thematic analysis as per 6 steps: familiarizing with the data; generating initial 
codes; searching for themes; reviewing potential themes; defining and naming 
themes; and producing the report)9. Analysis will be iterative and will be conducted by 
two independent qualitative researchers/coders. Triangulation will be used to cross-
check the observational field notes and transcripts of the audio interviews to evaluate 
the extent to which all evidence converges and corroborates.   
 
Patient and Public Involvement 
Patients and public were involved in this study throughout the co-design process and 
feasibility evaluation of the intervention. Patients and public involvement (PPI) in the 
co-design process includes individual interviews, surveys, focus group discussions 
and participation in workshops and feedback meetings. PPI started from identifying 
the problem, understanding determinants, and the real-world workshop discussions 
for topic refinement and prototype optimization. In the present feasibility study, patient 

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and HCPs participants’ feedback on the HEALing programme will be collected through 
individual interviews and surveys as part of the feasibility and acceptability analysis. 
Prior to disseminating findings in academic journals, we will conduct member checks 
with community partners, incorporating their comments into manuscripts, primarily in 
the discussion section (if any). When feasible, we invite community partners to co-
present at conferences and coauthor manuscripts.  
 
DISCUSSION  
 
Strengths  
This proof-of-concept study will provide evidence on the feasibility and acceptance of 
a personalised self-care support programme for primary care patients with DFU. The 
key strength of the study will be its substantial PPI throughout the intervention 
development and feasibility trial in the real world. Using PPI in direct collaboration with 
people affected by DFU will provide those who will receive the HEALing intervention 
an equal opportunity to make decisions about their own lives. People who use and 
receive the HEALing intervention with direct experience leading initiatives (co-
designing intervention) and getting involved throughout the feasibility trial will be at the 
heart of person-centred care and patient empowerment. Another strength of the study 
is its mixed-method approach with interview data used to complement the quantitative 
survey findings. Qualitative in-depth interviews with people living with DFU will ensure 
their voices and in-depth views can be captured and are not misrepresented.  
 
Limitations 
The design of a single arm has some limitations, such as having no outcome 
comparisons between groups that may yield biases in interpreting the results. As 
parallel control is lacking, comparisons could only be made with external historical 
data to evaluate the validity the study population, hence potential for selection bias in 
external comparison groups could be another limitation. Lastly, only short-term 
outcomes will be evaluated, thus sustainability of effects (if any) will not be known. 
Future randomised controlled trials including long-term outcomes with long study 
duration are recommended.  
 
Significance  
This pilot feasibility study will establish whether the MI-guided HEALing programme is 
feasible and acceptable to be implemented for supportive self-care for primary care 
patients with DFU. The study findings will directly inform the next steps in HEALing 
programme development, adaptation and testing future versions for self-management 
in future studies with potentially diverse samples in a range of settings. The information 
(i.e., preliminary efficacy) from this trial can be used to guide the refinement of a future 
trial in a larger scale to evaluate the effectiveness of the program for self-management 
intending to enhance self-efficacy and self-care behaviours for patients with DFU, as 
well as improve sustainability and substantiality of patient education.  
 
 
 
 

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