Encouraging patients to self‐care – the preliminary development and validation of the VeLUSET ^©, a self‐efficacy tool for venous leg ulcer patients, aged 60 years and over

Abstract

Venous leg ulceration has a high recurrence rate. Patients with healed or frequently recurring venous ulceration are required to perform self‐care behaviours to prevent recurrence or promote healing, but evidence suggests that many find these difficult to perform. Bandura's self‐efficacy theory is a widely used and robust behaviour change model and underpins many interventions designed to promote self‐care in a variety of chronic conditions. By identifying areas where patients may experience difficulty in performing self‐care, interventions can be developed to strengthen their self‐efficacy beliefs in performing these activities successfully. There are currently a variety of self‐efficacy scales available to measure self‐efficacy in a variety of conditions; but not a disease‐specific scale for use with venous ulcer patients. The aim of this study, therefore, was to develop and validate a disease‐specific, patient‐focused self‐efficacy scale for patients with healed venous leg ulceration. This scale will need further validation studies; however, it is ready for use in clinical practice and will enable practitioners to identify those patients who may need additional support in performing self‐care activities to prevent recurrence.

Introduction

Venous leg ulcer recurrence rates of between 45% and 69% have been reported in the literature 1, 2, 3, 4, 5, 6. Treatment aims tend to sit within an acute model of care, that is, a focus on healing as the optimum intervention objective, although this may not always be an achievable or realistic outcome because the underlying pathophysiology will always persist in the absence of surgical intervention. As such, chronic venous leg ulceration (CVLU) has a disease trajectory similar to chronic conditions such as rheumatoid arthritis and multiple sclerosis which often consists of an acute flare‐up or exacerbation of symptoms, alternating with periods of remission.

The economic impact of caring for patients with chronic conditions has resulted in government initiatives and policies designed to reduce the financial burden on the National Health Service (NHS) by encouraging patients towards self‐care 7, 8, 9, 10, 11. Initiatives such as the Expert Patient Programme 7 have been developed to teach patients self‐care skills and behaviours in order to manage their condition independently of health professionals (HPs) and comprise of self‐management courses, which are underpinned by self‐efficacy theory (SE) 12, 13 a health behaviour change theory that reports positive outcomes 14, 15, 16, 17.

Self‐care to prevent ulcer recurrence

There is some evidence in the literature that certain self‐care behaviours may help prevent ulcer recurrence, such as the life‐long wearing of compression hosiery post healing, 5, 18, 19 leg and ankle exercises 20, 21, 22, 23 and elevation 24, 25, 26; however, some patients find these difficult to perform or maintain 27, 28, 29. Furthermore, there is evidence within the literature that patients report receiving conflicting information on self‐care from HPs 30, 31, 32, 33, 34.

The UK government's current focus on prevention and encouraging patient self‐care and participation in their care has highlighted the need to develop a disease‐specific instrument to measure patients' perceived ability to perform such self‐care activities. This would enable HPs to identify those patients who may need an additional support in performing the activities, as well as an objective outcome measure of any nursing interventions designed to encourage self‐care. SE 12, 35 was identified as an appropriate theoretical framework to underpin the developing tool and has been used in many self‐care programmes for long‐term conditions 14, 17, 36.

Self‐efficacy as the underpinning theoretical construct

SE helps to explain health behaviour change and refers to a person's sense of confidence in his or her ability to perform a particular behaviour in a variety of circumstances 12, 35. SE has been used to explain the adoption of new health‐related behaviours such as 37, 38, 39, 40, the avoidance of risky lifestyle behaviours like smoking 41, and the maintenance of behaviours associated with chronic conditions in general 42, 43. Bandura 13 identified SE as central to the understanding of individuals' transactions with their environment and a core construct that mediates between knowledge and behaviours 44. Within the theory, outcome expectations are defined as beliefs that certain behaviours will result in a specific outcome, whereas SE outcome expectations are the perceptions of the individuals that they have the ability to execute that particular behaviour 13. Patients with low levels of SE tend to give up easily if unsuccessful in performing a given task, whereas persons with high levels of SE will persist until they succeed. SE can be enhanced using strategies such as succeeding in adopting a certain behaviour in the past (performance accomplishments), verbal persuasion to enact a behaviour, seeing others succeed in accomplishing tasks (vicarious experience) and physiological cues, such as maintain a stable haemoglobin A1c (HbA1c) in diabetic patients.

Self‐efficacy scales as objective measures of nursing interventions

A variety of scales have been developed to assess patients' SE pre‐ and post‐intervention as an objective outcome measurement, for example, the Self‐Efficacy for Diabetes Self‐Management scale 45 and the Arthritis Self‐Efficacy Scale 46, including the General Self‐Efficacy Scale 47. This is a generic scale, however, and Bandura 13 advocates using SE scales that are disease‐specific and designed to measure peoples' confidence in performing tasks specifically for their condition. Currently no SE scale has been developed to measure how confident patients' feel in performing leg ulcer‐specific self‐care activities.

Design and methodologies

The study used a mixed methods design and was conducted in two distinct phases between 2006 and 2012. Phase 1 used focus groups to collect qualitative data from which potential items for inclusion in the scale were generated. Although the aim of data collection was not theory generation per se, the methodology used a pragmatic approach to grounded theory which incorporated theoretical sampling, concurrent data generation and analysis, constant comparative analysis and preliminary coding to develop self‐efficacy statements in order to generate potential items for inclusion into the scale (qualitative). Phase 2 consisted of principal component analysis (PCA) and rotation methods to reduce the items and to identify dominant factors that formed sub‐scales for the developing tool (quantitative).

Phase 1 – focus groups to develop items

It is recommended that SE scales are patient‐focused and contain items developed by the people who are experiencing the phenomenon under study themselves 13. Following approval from local NHS Ethics and Research and Development organisations, a total of ten focus groups were organised. Table 1 gives details of the participants of the focus groups. Purposive sampling was used for the nurses and patient focus groups and data collection ceased when data saturation occurred. The focus groups with family or carers used theoretical sampling that had emerged from the preceding focus groups. Inclusion or exclusion criteria for the patient participants were: healed or recurrent ulcer of venous or mixed aetiology (suitable for compression therapy); age over 60 years, no cognitive impairment, English speaking and willing and able to give consent. There was no inclusion or exclusion criteria set for the HPs or patients' family or friends. Permission to recruit was sought and gained from local nurse managers and flyers inviting nurses to participate were distributed.

Table 1.

Details of focus groups and participants

Focus group number	Participants	Duration (minutes)	Number of participants	Male	Female	Age range (years)
1	Health professionals (pilot)	83	5	0	5	26–62
2	Health professionals	98	7	0	7	23–60
3	Health professionals	80	6	0	6	30–48
4	Patients	87	10	3	7	61–82
5	Patients	79	9	3	6	60–79
6	Patients	92	8	4	4	61–83
7	Patients	93	11	5	6	63–75
8	Patients	89	12	4	8	60–79
9	Family or carers	95	7	3	4	58–82
10	Family or carers	101	11	6	5	55–83

Data collection and analysis

The purpose of the study was explained to the participants and written consent for audio‐recording was obtained. The HP participants were then asked to describe the advice they gave to patients to prevent recurrence and the difficulties they felt patients experienced in performing self‐care activities to prevent ulcer recurrence. The focus group tapes were transcribed verbatim and entered into NVIVO₇ 48, a qualitative data management software programme which enabled categories and sub‐categories to be created. The data from each individual focus group were analysed and a topic guide outlining the main issues which had emerged from previous focus groups was developed. This enabled the researcher to pursue and discuss the emerging items within the next focus group, resulting in confirmation or rejection by the participants, thus drawing on the principles of grounded theory data analysis 49. As a result of this process, the topic guide was changed to reflect themes that had been confirmed or rejected by successive focus group participants. On completion of the HP focus groups, focus groups with leg ulcer patients and their family or carers were created, again using the constant comparative data analysis approach. Data collection ceased when no new themes emerged. The process of data collection, however, had resulted in rich, descriptive data and this was further analysed using grounded theory data analysis techniques 49. The dominant major themes to emerge consistently across all focus groups are given in Table 2.

Table 2.

Emergent dominant themes and sub‐themes following data analysis

Major themes	Sub‐themes
Looking for reasons	Trauma
	Avoiding situations
Living with continual uncertainty	Prior experiences
	Fear of recurrence
	Constant vigilance
	Coping strategies
	Seeking reassurance
	Being ‘checked out’
Restricted Lives	Limitations on everyday activities
	Maintaining personal hygiene
	Body image
	Difficulties in performing self‐care
Knowledge and education	Lack of knowledge on the part of health professionals
	Lack of knowledge on the part of the patient
	Receiving conflicting information
Normalising and adapting	Remaining optimistic
	Carrying on regardless
	Perseverance
	Adapting and innovation
	Friends and family support
Developing expertise	Navigating the system
	Being assertive
	Control issues in the patient/health professional relationship
	Identifying skilled health professionals

Data analysis and interpretation

The following gives three extracts from the data and illustrates how themes and self‐efficacy statements were developed.

I've got elastic stockings and there's only one complaint, they are very comfortable when they are on, but, boy, do I have a job getting them off. I was given an applicator, or whatever they call it, it's alright but too much messing around. It takes me a good 5–6 minutes to put it on…… (Theme: restricted lives; sub‐theme: difficulties in performing self‐care.)

Tool domain: daily self‐care tasks.

Self‐efficacy statement: ‘I am confident that I will be able to take my hosiery off daily’.

I don't think patients know a lot about leg ulcers cos (sic) nobody explains it to you, why you've got it, you know (Theme: knowledge and education; sub‐theme: lack of information on the part of the patient.)

Tool domain: developing expertise.

Self‐efficacy statement: ‘I am confident I understand why I have a venous leg ulcer’.

Life's got to go on, hasn't it? You can't be thinking about your legs all the time, can you? (Theme: normalising and adapting; sub‐theme: carrying on regardless.)

Tool domain: normal living.

Self‐efficacy statement: ‘I am confident I will still be able to lead a normal life even if my ulcer comes back’.

A more detailed presentation of the findings of this study phase will be published in the future in order to serve as an audit trail on the item development process.

Phase 2 – Tool development

The most commonly discussed issues identified from the focus group transcripts were developed into 111 statements which were considered to be too many for inclusion into the developing tool. Following an Ethics amendment application, a further focus group was organised with ten leg ulcer patients, the purpose of which was to ask the participants to discuss the items and decide whether some could be eliminated because of duplicity or irrelevance. Each item was reviewed and following discussion by the group, items were removed if they were considered to be repetitive, ambiguously worded or irrelevant or too specific for a particular sample. Examples of eliminated items related to a patient's ability to go swimming, going on holiday (with an open ulcer) and setting personal goals to achieve healing. The group felt these were irrelevant to them and, interestingly, that they had little control over the healing of their ulcer. The irrelevance of these items may have been due to the varying ages among the participants across the focus groups. Following group consensus, the items were reduced from 111 to 60.

Expert reviewers – content and face validity

The next phase of the scale development was to invite comments on these preliminary items from a panel of four experts in self‐efficacy and/or venous leg ulceration. A few comments were made about the length of the proposed scale, the wording and duplicity of some of the statements, and suggestions for possible items for inclusion were received, however, all agreed that the statements reflected the self‐efficacy construct and demonstrated strong content validity.

Preliminary administration of pilot scale (Phase 2a)

The 60 items were developed into self‐efficacy statements, for example, ‘I am confident I will be able to put my compression stockings on every day’ and were presented in Likert‐format, using a scale of 0–10, allowing respondents to indicate how much they agreed with each statement on a continuum from 0, completely disagree to 10, completely agree and were listed at random. Eight negatively worded items were developed to test for reliability of responses and response bias 50. The readability statistics facility on the Word^® (Microsoft Windows^® XP Office 2001) programme was used to determine readability statistics which indicated a Flesch Reading Ease Score of 72, and a Flesch Kinkaid Grade Level of 8.5, which 88% of the population would be able to understand. 51, 52. The front sheet introduced the study and requested basic demographic data, such as age, sex and number of ulcers.

A sample of 150 participants was required in order to carry out factor analysis and six leg ulcer clinics were approached by the researcher to recruit potential participants. The study was explained to the HPs, together with the inclusion or exclusion criteria. Copies of the pilot instrument, together with information leaflets and a stamped addressed envelope were left with the HPs to distribute to potential participants. Table 3 gives demographic details of the participants for both phases of the study.

Table 3.

Patient demographics – Phases 2a and 2b

Patient demographics	Phase 2a (n = 118) pilot		Phase 2b (n = 87) V.1
Sex distribution	Male	Female	Male	Female
	50.4% (n = 58)	49.6% (n = 57)	46% (n = 40)	54% (n = 47)
Mean age of participant	74.15 years (range 60–95; SD 10.966)		74.36 years (SD 10.416)
Smoker	Yes 13.6% (n = 16)	No 82.2% (n = 97)	Question removed following pilot
Do you have a carer?	Yes 3.4% (n = 4)a	No 48.3% (n = 57)a	Yes 17.2% (n = 15)	No 82.8% (n = 72)
Is this your first leg ulcer?	Yes 45.3% (n = 53)	No 54.7% (n = 64)	Yes 31.3% (n = 25)	No 66.3% (n = 53)
How many ulcers have you had?b	Mean 4.05 (SD 4.366) Trimmed mean 3.33c		Mean 3.51 (SD 4.319) Trimmed mean 2.92c
1–3	50% (n = 59)a		74.3% (n = 58)a
4–7	23.7% (n = 28)		12.8% (n = 10)
7>	9.3% (n = 11)		15.3% (n = 10)
	Range 1–19		Range 1–28
Has it healed now?	Yes	No	Yes	No
	47.9% (n = 56)a	52.1% (n = 61)	32.5% (n = 26)	67.5% (n = 54)
If healed, how long did it take? (months)b	Mean 12.13 months (SD 18.425)		Mean 23.65 months (SD 64.358)
	Trimmed mean 9.13 monthsc (SD 18.425c		Trimmed mean 11.33 months (SD 64.201)c
1–3	12.7% (n = 15)a		12.5% (n = 3)a
3–6	18.6% (n = 22)		4.6% (n = 4)
6–9	4.2% (n = 5)		3.4% (n = 3)
9–12	7.6% (n = 9)		6.9% (n = 6)
12–24	5% (n = 6)		3.4% (n = 3)
>30 months	4.9% (n = 6)		3.3% (n = 3)
	Range 1–120 months		Range 1–372 months
If it has not healed, how long have you had it? (months)b	Mean 32.57 (SD 75.054) Trimmed mean 19.20 months (SD 75.054)c		Mean 30.57 (SD 59.96) Trimmed mean 19.77 months (SD 59.964)c
1–12	30.4% (n = 36)a		30.8% (n = 27)a
12–24	10.1% (n = 12)		17.1% (n = 15)
24–48	4.2% (n = 5)		7.9% (n = 7)
48–72	4% (n = 5)		3.3% (n = 3)
>72	3.2% (n = 5)		6.6% (n = 6)
	Range 1–364)		Range (1–371)
Age first ulcer developed?	Mean 68 years SD 16.687 (range 70)		Mean 60.24 years SD 16.792 (range 73)

^aindicates missing data where figures do not total 100%.

^bgrouped into categories for presentation purposes.

^c5% trimmed mean pairwise exclusion.

Receipt of a completed questionnaire was taken as consent to participate; 210 copies of the pilot instrument were distributed, of which 148 were returned to the researcher. Unfortunately, 30 had been incorrectly completed and had to be eliminated from the data analysis. In total, 118 questionnaires were analysed, representing a response rate of 41%. This is considered to be an average response rate; however, the sample size for this phase was 115 (males n = 58; females n = 57; mean age 74.15 years; range 60.95; SD 10.966) and is considered a very small number for confirmatory component analysis 53. The type and size of the sample used may impact on the generalisability of the tool and must be acknowledged as a potential bias of the study 54.

Internal reliability

The PCA function on SPSS v.19 was used in order to produce a smaller number of factors that captured most of the variability in the pattern of correlations 50, 51, 52, 53, 54, 55. Analysis was performed using equamax rotation, eigenvalues of 1.0 and above, and factor loadings of 0.5 and above. The negatively worded items had loaded onto one factor, confirming that participants had found these difficult to complete. These were removed from the analysis, which was then repeated. Output interpretation revealed that seven factors needed to be extracted, which accounted for 78.2% of the variance. Two factors had strong similarities with other factors and were therefore combined, resulting in five factors overall which formed the sub‐scales. The number of items had been reduced from 60 to 36.

Phase 2b – Further validation and refinement of the VeLUSET

The 36 items were incorporated into the instrument within a similar layout as before. In addition, ten items that comprise the Generalized Self‐Efficacy Scale (GSE) 47 were incorporated in order to assess the construct validity and specificity of the developing scale in relation to the generic SE scale. The recruitment process for this phase was similar to that of the first pilot, however, the geographical area was extended further and included a mixture of clinics and district nursing patients in order to achieve the required sample size. A total of 150 questionnaires were distributed to patients who met the inclusion or exclusion criteria and who had not completed the first questionnaire. A total of 87 completed questionnaires were returned (n = 87; males n = 40; females n = 47; mean age 74.36 years (range 60–96; SD 10.416). Factor extraction was repeated, using the identical combination of equamax orthogonal rotation, eigenvalues of 1.0 and factor loadings of 0.5 and above, and 5 factors were extracted, explaining 78.3% of the total variance. The total number of items was reduced from 36 to 30. Correlations between the GSE scores and the VeLUSET scores were computed using Pearson product–moment correlation coefficient. Results indicated a strong positive correlation between the two scales (r = 0.564, n = 87, P < 0.001) with 31% shared variance.

Internal consistency reliability – Cronbach's alpha

Internal consistency reliability is concerned with the homogeneity of the items within a scale and is typically equated with Cronbach's alpha 56 which is used as a measure of internal reliability. DeVellis 50 suggests that a Cronbach's alpha should be above 0.70 for a scale although lower values are acceptable for a newly developed scale. The alpha value for the total scale was 0.931, indicating good internal consistency reliability, although the sample size was relatively small.

Alpha values for the GSE were computed (α = 0.901) and mean inter‐item correlation was 0.48, with values ranging from 0.71 to 0.108. Mean scores for the GSE and the VeLUSET were 31 (SD 5.93) and 282.32 (SD 54.17), respectively for this sample.

Table 4 gives details of the final items retained in the VeLUSET together with factor loadings and Cronbach's alphas.

Table 4.

Final domains of the VeLUSET with factor loadings and Cronbach Alphas

Domain	Scale mean if item deleted	Scale variance if item deleted	Corrected item‐total correlation	Factor loading	Cronbach's Alpha if item deleted
General self‐care					Overall subscaleα = 0.834
I understand why I need to wear my compression stockings for the rest of my life	225.92	1895.230	0.561	0.830	0.928
I will be able to check my compression stockings regularly to make sure they still fit me	226.07	1859.739	0.697	0.651	0.926
I will wear my hosiery even though my ulcer may come back	225.60	1891.360	0.681	0.730	0.927
I will try to see my nurse every 3–6 months to get new hosiery	224.91	1941.712	0.504	0.861	0.929
I understand why compression stockings will help stop my ulcer coming back	225.29	1888.719	0.697	0.681	0.927

	Scale mean if item deleted	Scale variance if item deleted	Corrected item‐total correlation	Factor loading	Overall subscale α = 0.851
Domain Daily self‐care tasks
I will be able to put my legs up to the level of my heart daily for 2 hours	227.66	1887.252	0.480	0.594	0.930
I will be able to put my compression stockings on every day	226.74	1859.080	0.579	0.713	0.928
I will be able to take my stockings off daily	226.30	1890.584	0.487	0.755	0.930
I will wear my compression stockings even though I have other health problems	225.46	1918.833	0.585	0.515	0.928
I will try to make putting my stockings on and off part of my everyday routine	225.82	1919.036	0.449	0.747	0.930
I am confident that my compression stockings will help stop my ulcer (s) coming back	225.52	1972.532	0.330	0.582	0.931
I will try to get help if I cannot put my stockings on or take them off myself	225.74	1906.360	0.551	0.532	0.928
I am confident that I will be able to do the leg exercises (heel raises/ankle circles) that I have been asked to do every day	226.09	1889.247	0.598	0.542	0.928
I am confident that I can lose some weight in the next 3 months if I need to	226.79	1911.166	0.486	0.679	0.929
I am confident that I can avoid standing for long periods during the day	225.51	1971.881	0.390	0.556	0.932
I am confident that I will try to avoid sitting down for too long during the day	225.80	1899.950	0.598	0.570	0.928
I am confident that I will be able to take a walk for at least half an hour every day	227.83	1855.633	0.545	0.643	0.929
I will still be able to lead a normal life even if my ulcer comes back	226.02	1931.023	0.504	0.746	0.929
I am confident that having a leg ulcer will not stop me going out if I want to	225.45	1920.669	0.571	0.696	0.928
I will still be able to go out and enjoy myself even though I wear compression stockings	225.22	1910.963	0.687	0.645	0.927
I am confident that I will be able to wear the types of clothes I want even though I have to wear compression stockings	225.55	1940.483	0.499	0.731	0.929

	Scale mean if item deleted	Scale variance if item deleted	Corrected item‐total correlation	Factor loading	Overall sub‐scale α = 0.828
Domain Developing expertise
I will try to remain positive that my ulcer will heal even when if it comes back	225.69	1936.310	0.513	0.616	0.929
I feel confident to ask questions if there is something I do not understand about my treatment	224.47	1962.345	0.586	0.504	0.929
I am confident I know why I have an ulcer	226.78	1909.661	0.423	0.716	0.930
I am able to recognise the signs that my ulcer is returning	225.32	1902.174	0.699	0.551	0.927
I am confident that I will be able to tell if a health professional gives me the wrong information about my ulcer/treatment	226.82	1892.873	0.527	0.656	0.929
I am confident I know where to go to get help if I think my ulcer is coming back	224.79	1935.236	0.622	0.731	0.928

	Scale mean if item deleted	Scale variance if item deleted	Corrected item‐total correlation	Factor loading	Overall sub‐scale α = 0.804
Domain Avoiding trauma
I am confident that I know how to avoid getting my legs knocked	226.33	1889.620	0.588	0.737	0.928
I am confident that I will be able to tell other people to be careful around my legs	225.39	1911.520	0.563	0.689	0.928
I will take extra care to stop my legs being knocked	225.47	1899.368	0.625	0.684	0.927

Test–retest reliability analysis

A random sample of 20 participants who had completed the scale in Phase 2 were approached 4 weeks later and requested to complete another scale to assess reliability of the VeLUSET over time. An additional question was added, enabling participants to indicate whether there had been a change in their leg ulcer status, that is, healed or recurred. Correlation using Pearson product–moment coefficient indicated a very strong positive relationship between test and retest scores (r = 0.92; n = 20; P < 0.001).

Discussion

The UK government's health policy on prevention and the promotion of self‐care and patient well‐being 11, 57, 58 has become a driver for HPs to develop clinical interventions that reflect this focus. CVLU is a long‐term condition, reflected by its high recurrence rates; however, review of the literature indicated that self‐care activities, such as wearing compression hosiery, performing ankle exercises and elevation may help to prevent recurrence. Nursing interventions, therefore, designed to encourage patients to self‐care may prevent ulcer recurrence and demonstrate additional clinical outcomes, such as enhancing patient well‐being 59. Interventions, such as self‐care management programmes specifically for patients with healed or frequently recurring ulceration may be developed in the future and the VeLUSET will provide an objective outcome measure of such interventions.

Within the literature, patients have described receiving conflicting advice on self‐care activities from HPs 30, 31, 32, 33, 34 and an additional benefit of the VeLUSET is that the levels of self‐care activities, such as leg elevation, ankle exercises and taking a walk are clearly defined, for example, elevation for 2 hours daily. This will ensure that the self‐care advice patients receive is consistent and evidence based.

Preliminary reliability studies have revealed that the VeLUSET has good internal consistency, with an overall α of 0.931 for the total scale and for the subscales (α = 0.834, 0.851, 0.753, 0.828 and 0.804) which is considered good for a newly developed scale 50, although the limitations posed by the small sample must be acknowledged. Correlations between the GSE Scale and the VeLUSET scores using Pearson product–moment correlation coefficient indicated a strong positive correlation between the two scales; however, there was no significant difference between the scores for males and females. Temporal stability of the VeLUSET was computed using test–retest reliability which also revealed a very strong positive relationship between the test and retest scores over a 4‐week period.

Limitations

The primary limitation of the study is that the tool has been developed to assess self‐efficacy in patients, aged 60 years and over. It is recognised within the literature that VLU predominantly affects older people 60, 61, however, younger patients also develop ulceration and the tool may be inappropriate for this client group. A further limitation is that the participants in this study were reasonably active, mobile patients who attended leg ulcer clinics; however, a large proportion of patients are housebound and inactive because of multiple comorbidities and the items in the VeLUSET may not be applicable to this patient group. Consequently, the tool is currently unsuitable to measure self‐efficacy in these patient groups and further development, validation and refinement in the future may be required. Finally, the small sample size used to conduct Factor analysis (FA) means that the correlation coefficients among the variables are less reliable and the factors obtained may not be as generalisable as those derived from larger samples.

Conclusion

This paper has described the preliminary validation and development of a tool to measure how confident patients feel in performing the self‐care activities which may help to reduce venous ulcer recurrence. As a result, HPs will be in a position to identify those patients who may need additional support in performing them successfully. The self‐efficacy statements were developed directly from focus group transcripts and the VeLUSET therefore reflects the views and experiences of venous leg ulcer patients, aged 60 years and over and the HPs who care for them. The study used self‐efficacy as a conceptual framework, which will enable further development and refinement in the future. These results indicate that the VeLUSET, although still in need of further validation, can be considered a reliable instrument to measure patient's SE levels in performing self‐care within clinical practice. There is, to the authors' knowledge, currently no other SE tool available for use in this patient group and this study has now filled a gap in current venous leg ulcer research.

Brown A, Kendall S, Flanagan M, Cottee M. Encouraging patients to self‐care – the preliminary development and validation of the VeLUSET^©, a self‐efficacy tool for venous leg ulcer patients, aged 60 years and over.