Randomised controlled trial of a hypothyroid educational booklet to improve thyroxine adherence

Michael A Crilly, A. Esmail

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Background Non-adherence with medication prescribed for chronic disease is ubiquitous and undermines the benefits of effective therapy.

Aim To evaluate the influence of an educational booklet on thyroxine adherence and health in patients with primary hypothyroidism.

Design of study Unblinded randomised clinical trial of individual patients (by stratified permutated blocks) to received an 'educational booklet' or 'usual care'.

Setting Three general practices in the north-west of England serving 497 adults with primary hypothyroidism (prevalence 1.5%).

Method A total of 332 adults who had been prescribed thyroxine for hypothyroidism were allocated to either a group that was posted a hypothyroid booklet addressing lay health beliefs or to a group that received usual care. Outcomes were mean within-subject change over 3 months in thyroid stimulating hormone (TSH), the SF-36 domains of vitality and general health, and a hypothyroid symptoms index. All results were concealed until the end of the trial.

Results A total of 332 randomised patients were analysed by 'intention to treat' (TSH available for 330 patients). Groups were comparable at baseline, although 'undetectable TSH' was higher in the intervention than the control group (20% versus 13%). Mean change in TSH was -0.11 mIU/L (intervention) and -0.12mlU/L (control). An absolute difference of 0.01 mIU/L (95% confidence interval [CI] -0.93 to 0.94 mlU/L). Analysis adjusted (ANCOVA) for baseline TSH produced a difference of -0.12mlU/L (95% CI = -1.97 to 1.95). Changes in SF-36 and hypothyroid index were minimal. Trial participants were younger than non-participants and more likely to have a previous TSH in the normal range.

Conclusion Brief intervention with an educational booklet has no influence on thyroxine adherence or health in patients with primary hypothyroidism. These findings do not support the routine distribution of health educational materials to improve medication adherence.

Original languageEnglish
Pages (from-to)362-368
Number of pages6
JournalThe British Journal of General Practice
Volume55
Issue numberMay
Publication statusPublished - 2005

Keywords

  • health education
  • hypothyroidism
  • patient compliance
  • randomised controlled trial
  • thyroxine
  • PATIENT COMPLIANCE
  • GENERAL-PRACTICE
  • HYPERTHYROIDISM
  • MANAGEMENT
  • COMMUNITY

Cite this

Randomised controlled trial of a hypothyroid educational booklet to improve thyroxine adherence. / Crilly, Michael A; Esmail, A.

In: The British Journal of General Practice, Vol. 55, No. May, 2005, p. 362-368.

Research output: Contribution to journalArticle

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abstract = "Background Non-adherence with medication prescribed for chronic disease is ubiquitous and undermines the benefits of effective therapy.Aim To evaluate the influence of an educational booklet on thyroxine adherence and health in patients with primary hypothyroidism.Design of study Unblinded randomised clinical trial of individual patients (by stratified permutated blocks) to received an 'educational booklet' or 'usual care'.Setting Three general practices in the north-west of England serving 497 adults with primary hypothyroidism (prevalence 1.5{\%}).Method A total of 332 adults who had been prescribed thyroxine for hypothyroidism were allocated to either a group that was posted a hypothyroid booklet addressing lay health beliefs or to a group that received usual care. Outcomes were mean within-subject change over 3 months in thyroid stimulating hormone (TSH), the SF-36 domains of vitality and general health, and a hypothyroid symptoms index. All results were concealed until the end of the trial.Results A total of 332 randomised patients were analysed by 'intention to treat' (TSH available for 330 patients). Groups were comparable at baseline, although 'undetectable TSH' was higher in the intervention than the control group (20{\%} versus 13{\%}). Mean change in TSH was -0.11 mIU/L (intervention) and -0.12mlU/L (control). An absolute difference of 0.01 mIU/L (95{\%} confidence interval [CI] -0.93 to 0.94 mlU/L). Analysis adjusted (ANCOVA) for baseline TSH produced a difference of -0.12mlU/L (95{\%} CI = -1.97 to 1.95). Changes in SF-36 and hypothyroid index were minimal. Trial participants were younger than non-participants and more likely to have a previous TSH in the normal range.Conclusion Brief intervention with an educational booklet has no influence on thyroxine adherence or health in patients with primary hypothyroidism. These findings do not support the routine distribution of health educational materials to improve medication adherence.",
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AB - Background Non-adherence with medication prescribed for chronic disease is ubiquitous and undermines the benefits of effective therapy.Aim To evaluate the influence of an educational booklet on thyroxine adherence and health in patients with primary hypothyroidism.Design of study Unblinded randomised clinical trial of individual patients (by stratified permutated blocks) to received an 'educational booklet' or 'usual care'.Setting Three general practices in the north-west of England serving 497 adults with primary hypothyroidism (prevalence 1.5%).Method A total of 332 adults who had been prescribed thyroxine for hypothyroidism were allocated to either a group that was posted a hypothyroid booklet addressing lay health beliefs or to a group that received usual care. Outcomes were mean within-subject change over 3 months in thyroid stimulating hormone (TSH), the SF-36 domains of vitality and general health, and a hypothyroid symptoms index. All results were concealed until the end of the trial.Results A total of 332 randomised patients were analysed by 'intention to treat' (TSH available for 330 patients). Groups were comparable at baseline, although 'undetectable TSH' was higher in the intervention than the control group (20% versus 13%). Mean change in TSH was -0.11 mIU/L (intervention) and -0.12mlU/L (control). An absolute difference of 0.01 mIU/L (95% confidence interval [CI] -0.93 to 0.94 mlU/L). Analysis adjusted (ANCOVA) for baseline TSH produced a difference of -0.12mlU/L (95% CI = -1.97 to 1.95). Changes in SF-36 and hypothyroid index were minimal. Trial participants were younger than non-participants and more likely to have a previous TSH in the normal range.Conclusion Brief intervention with an educational booklet has no influence on thyroxine adherence or health in patients with primary hypothyroidism. These findings do not support the routine distribution of health educational materials to improve medication adherence.

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KW - thyroxine

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KW - GENERAL-PRACTICE

KW - HYPERTHYROIDISM

KW - MANAGEMENT

KW - COMMUNITY

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VL - 55

SP - 362

EP - 368

JO - The British Journal of General Practice

JF - The British Journal of General Practice

SN - 0960-1643

IS - May

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