Interventions for helping people adhere to compression treatments to aid healing of venous leg ulcers

Background

Venous leg ulcers take weeks or months to heal, cause distress, and are very costly for health services. Although compression using bandages or stockings helps healing and prevents recurrence, many people do not adhere to compression therapy. Therefore, interventions that promote the wearing of compression should improve healing and prevent recurrence of venous ulcers.

Study characteristics

This updated review (current to 22 June 2015) included three randomised controlled trials. One study conducted in Australia compared standard wound care (venous ulcer treatment, advice and support, follow-up management and preventive care) in a community clinic called 'Leg Club' (34 participants) with the same wound care in the home by a nurse (33 participants). Another study (184 participants) compared a community-based exercise and behaviour modification programme called 'Lively Legs' for promoting adherence with compression therapy and physical exercise plus usual care (wound care, compression bandages at an outpatient clinic) with 'usual care' alone in 11 outpatient dermatology clinics in the Netherlands. A third small study (20 participants) compared a patient educational intervention to improve knowledge of venous disease and ulcer management. The intervention was delivered via video or via written pamphlet for people attending a wound healing research clinic in Miami, USA. Participants in all studies were aged 60 or more, with a venous leg ulcer.

Key results

The Leg Club®, a community-based clinic, did not improve healing of venous leg ulcers or quality of life any more than nurse home-visit care, but may result in less pain after six months. Seventeen more people out of 100 were healed after participating in Leg Club (46/100 people in Leg Club healed compared with 29/100 people having usual home care); this difference was not statistically significant and could have occurred by chance. Leg Club participants rated their quality of life 0.85 points better than those receiving home care, assessed on a 10 point scale. Leg Club participants rated their pain at six months 12.75 points lower than the home care group, assessed on a 100 point scale. This trial did not report whether Leg Club clinics improve adherence to compression, time to healing, or prevent recurrence more than home care.

It is not clear whether Lively Legs®, a community-based self-management programme, improves ulcer healing or recurrence after 18 months compared with usual care. It is not clear whether Lively Legs® influences adherence to compression therapy. The trial did not report whether the Lively Legs self-management programme clinics improve time to healing of ulcers, reduce pain, or improve quality of life any more than usual care in a wound clinic.

It is unclear if patient education delivered by video or via a pamphlet improves healing or recurrence, as the study did not measure any outcomes relevant to this review.

No other interventions were identified.

Quality of the evidence

It is unclear whether community-based clinics to promote adherence to compression therapy either promote adherence or improve ulcer healing or recurrence. The available evidence is low quality due to the risk of bias in the included studies and their small sample sizes which lead to great imprecision and uncertainty. One single small trial that evaluated an education intervention failed to measure the outcomes we considered important for this review such as ulcer healing and recurrence, and adherence. Further high quality studies are likely to change the outcome of this review.

We know that compression therapy is effective, but do not know which interventions improve adherence to compression therapy.

Up-to-date June 2015.

Authors' conclusions: 

It is unclear whether interventions designed to help people adhere to compression therapy improve venous ulcer healing and reduce recurrence. There is a lack of trials of interventions that promote adherence to compression therapy for venous ulcers.

Read the full abstract...
Background: 

Chronic venous ulcer healing is a complex clinical problem that requires intervention from skilled, costly, multidisciplinary wound-care teams. Compression therapy has been shown to help heal venous ulcers and to reduce recurrence. It is not known which interventions help people adhere to compression treatments. This review is an update of a previous Cochrane review.

Objectives: 

To assess the benefits and harms of interventions designed to help people adhere to venous leg ulcer compression therapy, to improve healing and prevent recurrence after healing.

Search strategy: 

In June 2015, for this first update, we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched trial registries, and reference lists of relevant publications for published and ongoing trials. There were no language or publication date restrictions.

Selection criteria: 

We included randomised controlled trials (RCTs) of interventions that aim to help people with venous leg ulcers adhere to compression treatments compared with usual care, or no intervention, or another active intervention. Our main outcomes were ulcer healing, ulcer recurrence, quality of life, pain, adherence to compression therapy and number of people with adverse events.

Data collection and analysis: 

Two review authors independently selected studies for inclusion, extracted data, assessed the risk of bias of each included trial, and assessed overall quality of evidence for the main outcomes in 'Summary of findings' tables.

Main results: 

One randomised controlled trial was added to this update making a total of three. One ongoing study was also identified.

One trial (67 participants) compared a community-based Leg Club® that provided mechanisms for peer-support, assistance with goal setting and social interaction with home-based care. There was no clear difference in healing rates at three months (12/28 people healed in Leg Club group versus 7/28 in home-based care group; risk ratio (RR) 1.71, 95% confidence interval (CI) 0.79 to 3.71); or six months (15/33 healed in Leg Club group versus 10/34 in home-based care group; RR 1.55, 95% CI 0.81 to 2.93); or in quality of life outcomes at six months (MD 0.85 points, 95% CI -0.13 to 1.83; 0 to 10 point scale). The Leg Club may lead to a small reduction in pain at six months, that may not be clinically significant (MD -12.75 points, 95% CI -24.79, -0.71; 0 to 100 point scale, 15 point reduction is usually considered the minimal clinically important difference) (low quality evidence downgraded for risk of selection bias and imprecision).

Another trial (184 participants) compared a community-based, nurse-led self-management programme of six months' duration promoting physical activity (walking and leg exercises) and adherence to compression therapy via counselling and behaviour modification (Lively Legs®) with usual care in a wound clinic. At 18 months follow-up, there were no clear differences in healing rates (51/92 healed in Lively Legs group versus 41/92 in usual care group; RR 1.24 (95% CI 0.93 to 1.67)); rates of recurrence of venous leg ulcers (32/69 with recurrence in Lively Legs group versus 38/67 in usual care group; RR 0.82 (95% CI 0.59 to 1.14)); or adherence to compression therapy (42/92 people fully adherent in Lively Legs group versus 41/92 in usual care group; RR 1.02 (95% CI 0.74 to 1.41)). The evidence from this trial was also downgraded to low quality due to risk of selection bias and imprecision.

A single study compared patient education delivered via video with education delivered by text (pamphlet). However, no outcomes relevant to this review were reported.

We found no studies that investigated other interventions to promote adherence to compression therapy.

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