<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02250235</url>
  </required_header>
  <id_info>
    <org_study_id>111154_14238</org_study_id>
    <nct_id>NCT02250235</nct_id>
  </id_info>
  <brief_title>Piloting an Intervention for Improving Treatment Adherence</brief_title>
  <official_title>Piloting a Novel Behaviour Change Intervention for Improving Treatment Adherence in Haemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hertfordshire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Hertfordshire</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Helping patient with long-term conditions to make informed decisions about adherence to their&#xD;
      treatment is an important element in facilitating self-management. Estimates of non-adherence&#xD;
      to treatment in people living with long-term conditions are typically high, averaging at&#xD;
      around 50%.This not only impacts negatively on patient outcomes but also places a significant&#xD;
      financial burden on healthcare provision.&#xD;
&#xD;
      While clinical efforts have focused on promoting patient self-management, with some success,&#xD;
      work in Psychology on behaviour change has had little influence on clinical practice. In this&#xD;
      project, the team wish to evaluate the potential for a novel intervention from the behaviour&#xD;
      change literature, self-affirmation, to promote improved fluid control among non-adherent&#xD;
      patients. The intervention works by promoting a patient's sense-of-self (self-affirmation),&#xD;
      which has been shown to modify the patient's acceptance of health-risk information, their&#xD;
      self-efficacy, their intention to change, and subsequently their behaviour.&#xD;
&#xD;
      A randomised controlled pilot trial is proposed. The trial is designed to build upon routine&#xD;
      education about fluid control during dialysis visits, and will compare a group of patients&#xD;
      who have received an intervention to boost their sense-of-self (self-affirmation arm) to a&#xD;
      control group (control arm). Patients in the self-affirmation arm should have a more positive&#xD;
      evaluation of the health-risk information about fluid management, feel more able to, and&#xD;
      intend to change their fluid control behaviour, and subsequently have lower interdialytic&#xD;
      weight gain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People living with renal failure have to endure a demanding treatment regimen to keep them&#xD;
      alive including haemodialysis, a restricted diet and fluid intake and multiple drug&#xD;
      treatments. These demands have a profound effect on the patient's quality of life. It is not&#xD;
      surprising that many find it very difficult to manage some treatments even when they are&#xD;
      known to be important for the patient's survival. Restricting fluid intake (often as little&#xD;
      as 500ml per/day) is an essential treatment for many patients with advanced kidney failure&#xD;
      receiving haemodialysis, but many find it difficult to adhere. Estimates of fluid restriction&#xD;
      non-adherence range between 10-70%. Not adhering to the recommended maximum fluid intake&#xD;
      leads to fluid overload, which is associated with pulmonary oedema, cardiovascular disease&#xD;
      and premature death.&#xD;
&#xD;
      Understanding how to help patients improve their treatment adherence is challenging and&#xD;
      multifaceted. A recent Cochrane Review concluded that: &quot;For long-term treatments, no simple&#xD;
      intervention, and only some complex ones, led to improvements in health outcomes.&quot;. The&#xD;
      healthcare service has tried to help patients by promoting the patient's own role in their&#xD;
      healthcare and in educating patients about their illness and the treatments. However, it is&#xD;
      widely acknowledged that education alone is insufficient to change a patient's behaviour.&#xD;
      Educating patients about the consequences of non-adherence is often unsuccessful as for some&#xD;
      patients, they have become entrenched in poor health care behaviour over extended periods of&#xD;
      time. In this case, repeated exposure of the patient to threatening health-risk information&#xD;
      might be ineffective as the patient has likely become well rehearsed in discounting the&#xD;
      information being provided, and the behaviour of the patient will not change.&#xD;
&#xD;
      The proposed study is designed to investigate a novel intervention to promote behaviour&#xD;
      change that has been shown to be effective in changing behaviour in public health (e.g.&#xD;
      unhealthy dietary intake, unsafe sun exposure, hazardous drinking and smoking cessation) The&#xD;
      intervention is simple to implement, requires little training of staff and may have major&#xD;
      benefits for the patients and the NHS. The intervention is based on self-affirmation theory.&#xD;
      Central to this body of work is the recognition that most health-risk education confronts&#xD;
      people with information that is threatening, both to survival, and to their sense of self.&#xD;
      The person's response is to interpret the information in a way that reduces the threat to&#xD;
      them, for example by denigrating the veracity of the information. In turn the bias with which&#xD;
      the information is interpreted reduces its ability to change behaviour. The theory suggests&#xD;
      that if the person's sense of their own worth (e.g. sense-of-self) is boosted at the time of&#xD;
      receiving the threatening health-risk message, the person is less likely to interpret the&#xD;
      information in a biased way, rendering them more likely to accept the message, have increased&#xD;
      intention to change and believe that they can (self efficacy), and ultimately change their&#xD;
      behaviour. For example, Armitage examined adults' reactions to alcohol education materials,&#xD;
      and in a randomised controlled trial compared participants who self-affirmed by completing an&#xD;
      experimental questionnaire with participants who completed a control questionnaire.&#xD;
      Self-affirmation not only significantly increased participants' receptiveness to the message,&#xD;
      but also improved the effectiveness of the education in that 29% (27/92) fewer people were&#xD;
      engaged in hazardous drinking at the end of the study if they had self-affirmed.&#xD;
&#xD;
      Until recently, this behaviour change intervention method had not been tested in a patient&#xD;
      group experiencing a long-term condition like renal failure. In a recent pilot study (UKCRN&#xD;
      Portfolio study 74185), the team evaluated the potential for a self-affirmation intervention&#xD;
      to promote improved phosphate medication adherence among non-adherent patients. Interim&#xD;
      results from this study have highlighted key issues for which further research is necessary.&#xD;
      Firstly, this intervention is known to be more effective in people with low motivation and&#xD;
      this informed the recruitment strategy, targeting patients who appeared (on the basis of high&#xD;
      serum phosphate levels) to be non-adherent in taking their phosphate medication. However,&#xD;
      despite the patient sample's higher average phosphate levels, the majority of the patient&#xD;
      group reported to be motivated to improve phosphate control. Therefore, it is likely that for&#xD;
      many of these patients there are other reasons for their higher average phosphate levels,&#xD;
      such as forgetting to take their medication. In the group of patients who did report low&#xD;
      motivation to taking their medication (25% of the sample), the effects of the&#xD;
      self-affirmation were observed. There was a trend for patients who self-affirmed, to report&#xD;
      the health-risk message to be higher quality; greater self-efficacy and intention to improve&#xD;
      phosphate control and ultimately their serum phosphate levels were significantly reduced at&#xD;
      one month compared with the control group. It is important to now test the intervention with&#xD;
      a larger group of patients reporting low motivation towards the required health behaviour.&#xD;
      The team identified another treatment (fluid management) that most renal patients must follow&#xD;
      and evaluated 93 patients' thoughts about managing their fluid intake. The results of this&#xD;
      brief study suggest that a larger proportion of patients are less motivated to manage their&#xD;
      fluid intake and therefore, assessing the feasibility and efficacy of the self-affirmation&#xD;
      intervention would be achievable in this treatment group. Fluid management is a central&#xD;
      adherence issue to address as it is not only clinically very important but it is a&#xD;
      particularly difficult aspect of treatment for patients to manage.&#xD;
&#xD;
      The second issue that arose in the first study is the longevity of the intervention. The&#xD;
      apparent effects of self-affirmation on behaviour change to improve phosphate control&#xD;
      observed at one month were not sustained at three month follow-up which suggests that&#xD;
      self-affirmation might require repeated interventions. An important feature of this new study&#xD;
      would be to include repeated self-affirmations in the intervention group to investigate this&#xD;
      further.&#xD;
&#xD;
      A randomised controlled pilot trial is proposed. The study aims to recruit 120 patients&#xD;
      across a network of dialysis units, focussing on patients who have higher than average&#xD;
      interdialytic weight gains (IDWG). The trial is designed to build upon routine education&#xD;
      about fluid management during dialysis visits, and will compare a group of patients who have&#xD;
      received a self-affirmation intervention to boost their sense-of-self (self-affirmation arm)&#xD;
      to a control group (control arm). It is expected that patients in the self-affirmation arm&#xD;
      should have a more positive evaluation of the health-risk information about fluid management,&#xD;
      feel more able to, and intend to change their fluid control behaviour. The appropriate&#xD;
      methods of analysis include logistic regression, and mixed multilevel models, but the&#xD;
      relatively small sample size will limit the extent of the modelling that can be undertaken.&#xD;
      Thus the aim of the analysis will be examine the size of the observed effects and to design a&#xD;
      larger study. The study will inform the extent to which psychological and clinical factors&#xD;
      contribute to the outcome and should be used in future studies.&#xD;
&#xD;
      As this intervention is targeting non-adherent patients (as defined by higher IDWG levels)&#xD;
      and therefore not necessarily representative of all patients on dialysis, it is important to&#xD;
      establish the true clinical context. Patients who appear to be managing their treatment well,&#xD;
      based on their current clinical measures, might well be highly motivated. However, it is also&#xD;
      possible that some of those patients also experience low motivation, which in time, as their&#xD;
      illness becomes more severe, would be revealed by worsening adherence and clinical outcomes.&#xD;
      Thus, the study also aims to examine the psychological and clinical factors associated with&#xD;
      treatment adherence and non-adherence in a wider patient sample.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported appraisal of health risk information</measure>
    <time_frame>Collected immediately after presentation of health risk information (baseline)</time_frame>
    <description>Perceptions of the health risk, intention and self efficacy towards future treatment adherence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interdialytic weight-gain (IDWG)</measure>
    <time_frame>Over 12 months</time_frame>
    <description>Clinical measure obtained in routine clinical care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <arm_group>
    <arm_group_label>Self-affirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the self-affirmation arm, the patients completed a 10 item questionnaire about their past acts of kindness (self-affirmation) prior to reading the health risk information.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control patients completed 10 matched control questions with no self-affirming properties, prior to reading the health risk information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health risk information</intervention_name>
    <arm_group_label>Self-affirmation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult (over 18 years) haemodialysis patients&#xD;
&#xD;
          2. Fluency in spoken and written English&#xD;
&#xD;
          3. ≥ 3 months from initiation of dialysis&#xD;
&#xD;
          4. Three month Interdialytic Weight Gain (IDWG) &gt; 2.0 kg*&#xD;
&#xD;
          5. Residual renal urea clearance (KRU) &lt;1ml/min or reported urine output&lt;200mls per day.*&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hospitalised at the time of study or during the two months prior for reasons other&#xD;
             than dialysis&#xD;
&#xD;
          2. Being treated for other condition assessed as compromising treatment or participation&#xD;
             in study (e.g. mental health)&#xD;
&#xD;
          3. In preparation for live donor transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Hertfordshire</investigator_affiliation>
    <investigator_full_name>Vari Wileman</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250235
org study id: 111154_14238
nct id: NCT02250235
lead sponsor: 
has dmc: Yes
Helping patient with long-term conditions to make informed decisions about adherence to their
      treatment is an important element in facilitating self-management. Estimates of non-adherence
      to treatment in people living with long-term conditions are typically high, averaging at
      around 50%.This not only impacts negatively on patient outcomes but also places a significant
      financial burden on healthcare provision.

      While clinical efforts have focused on promoting patient self-management, with some success,
      work in Psychology on behaviour change has had little influence on clinical practice. In this
      project, the team wish to evaluate the potential for a novel intervention from the behaviour
      change literature, self-affirmation, to promote improved fluid control among non-adherent
      patients. The intervention works by promoting a patient's sense-of-self (self-affirmation),
      which has been shown to modify the patient's acceptance of health-risk information, their
      self-efficacy, their intention to change, and subsequently their behaviour.

      A randomised controlled pilot trial is proposed. The trial is designed to build upon routine
      education about fluid control during dialysis visits, and will compare a group of patients
      who have received an intervention to boost their sense-of-self (self-affirmation arm) to a
      control group (control arm). Patients in the self-affirmation arm should have a more positive
      evaluation of the health-risk information about fluid management, feel more able to, and
      intend to change their fluid control behaviour, and subsequently have lower interdialytic
      weight gain.
People living with renal failure have to endure a demanding treatment regimen to keep them
      alive including haemodialysis, a restricted diet and fluid intake and multiple drug
      treatments. These demands have a profound effect on the patient's quality of life. It is not
      surprising that many find it very difficult to manage some treatments even when they are
      known to be important for the patient's survival. Restricting fluid intake (often as little
      as 500ml per/day) is an essential treatment for many patients with advanced kidney failure
      receiving haemodialysis, but many find it difficult to adhere. Estimates of fluid restriction
      non-adherence range between 10-70%. Not adhering to the recommended maximum fluid intake
      leads to fluid overload, which is associated with pulmonary oedema, cardiovascular disease
      and premature death.

      Understanding how to help patients improve their treatment adherence is challenging and
      multifaceted. A recent Cochrane Review concluded that: "For long-term treatments, no simple
      intervention, and only some complex ones, led to improvements in health outcomes.". The
      healthcare service has tried to help patients by promoting the patient's own role in their
      healthcare and in educating patients about their illness and the treatments. However, it is
      widely acknowledged that education alone is insufficient to change a patient's behaviour.
      Educating patients about the consequences of non-adherence is often unsuccessful as for some
      patients, they have become entrenched in poor health care behaviour over extended periods of
      time. In this case, repeated exposure of the patient to threatening health-risk information
      might be ineffective as the patient has likely become well rehearsed in discounting the
      information being provided, and the behaviour of the patient will not change.

      The proposed study is designed to investigate a novel intervention to promote behaviour
      change that has been shown to be effective in changing behaviour in public health (e.g.
      unhealthy dietary intake, unsafe sun exposure, hazardous drinking and smoking cessation) The
      intervention is simple to implement, requires little training of staff and may have major
      benefits for the patients and the NHS. The intervention is based on self-affirmation theory.
      Central to this body of work is the recognition that most health-risk education confronts
      people with information that is threatening, both to survival, and to their sense of self.
      The person's response is to interpret the information in a way that reduces the threat to
      them, for example by denigrating the veracity of the information. In turn the bias with which
      the information is interpreted reduces its ability to change behaviour. The theory suggests
      that if the person's sense of their own worth (e.g. sense-of-self) is boosted at the time of
      receiving the threatening health-risk message, the person is less likely to interpret the
      information in a biased way, rendering them more likely to accept the message, have increased
      intention to change and believe that they can (self efficacy), and ultimately change their
      behaviour. For example, Armitage examined adults' reactions to alcohol education materials,
      and in a randomised controlled trial compared participants who self-affirmed by completing an
      experimental questionnaire with participants who completed a control questionnaire.
      Self-affirmation not only significantly increased participants' receptiveness to the message,
      but also improved the effectiveness of the education in that 29% (27/92) fewer people were
      engaged in hazardous drinking at the end of the study if they had self-affirmed.

      Until recently, this behaviour change intervention method had not been tested in a patient
      group experiencing a long-term condition like renal failure. In a recent pilot study (UKCRN
      Portfolio study 74185), the team evaluated the potential for a self-affirmation intervention
      to promote improved phosphate medication adherence among non-adherent patients. Interim
      results from this study have highlighted key issues for which further research is necessary.
      Firstly, this intervention is known to be more effective in people with low motivation and
      this informed the recruitment strategy, targeting patients who appeared (on the basis of high
      serum phosphate levels) to be non-adherent in taking their phosphate medication. However,
      despite the patient sample's higher average phosphate levels, the majority of the patient
      group reported to be motivated to improve phosphate control. Therefore, it is likely that for
      many of these patients there are other reasons for their higher average phosphate levels,
      such as forgetting to take their medication. In the group of patients who did report low
      motivation to taking their medication (25% of the sample), the effects of the
      self-affirmation were observed. There was a trend for patients who self-affirmed, to report
      the health-risk message to be higher quality; greater self-efficacy and intention to improve
      phosphate control and ultimately their serum phosphate levels were significantly reduced at
      one month compared with the control group. It is important to now test the intervention with
      a larger group of patients reporting low motivation towards the required health behaviour.
      The team identified another treatment (fluid management) that most renal patients must follow
      and evaluated 93 patients' thoughts about managing their fluid intake. The results of this
      brief study suggest that a larger proportion of patients are less motivated to manage their
      fluid intake and therefore, assessing the feasibility and efficacy of the self-affirmation
      intervention would be achievable in this treatment group. Fluid management is a central
      adherence issue to address as it is not only clinically very important but it is a
      particularly difficult aspect of treatment for patients to manage.

      The second issue that arose in the first study is the longevity of the intervention. The
      apparent effects of self-affirmation on behaviour change to improve phosphate control
      observed at one month were not sustained at three month follow-up which suggests that
      self-affirmation might require repeated interventions. An important feature of this new study
      would be to include repeated self-affirmations in the intervention group to investigate this
      further.

      A randomised controlled pilot trial is proposed. The study aims to recruit 120 patients
      across a network of dialysis units, focussing on patients who have higher than average
      interdialytic weight gains (IDWG). The trial is designed to build upon routine education
      about fluid management during dialysis visits, and will compare a group of patients who have
      received a self-affirmation intervention to boost their sense-of-self (self-affirmation arm)
      to a control group (control arm). It is expected that patients in the self-affirmation arm
      should have a more positive evaluation of the health-risk information about fluid management,
      feel more able to, and intend to change their fluid control behaviour. The appropriate
      methods of analysis include logistic regression, and mixed multilevel models, but the
      relatively small sample size will limit the extent of the modelling that can be undertaken.
      Thus the aim of the analysis will be examine the size of the observed effects and to design a
      larger study. The study will inform the extent to which psychological and clinical factors
      contribute to the outcome and should be used in future studies.

      As this intervention is targeting non-adherent patients (as defined by higher IDWG levels)
      and therefore not necessarily representative of all patients on dialysis, it is important to
      establish the true clinical context. Patients who appear to be managing their treatment well,
      based on their current clinical measures, might well be highly motivated. However, it is also
      possible that some of those patients also experience low motivation, which in time, as their
      illness becomes more severe, would be revealed by worsening adherence and clinical outcomes.
      Thus, the study also aims to examine the psychological and clinical factors associated with
      treatment adherence and non-adherence in a wider patient sample.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Self-reported appraisal of health risk information
time frame: Collected immediately after presentation of health risk information (baseline)
description: Perceptions of the health risk, intention and self efficacy towards future treatment adherence
measure: Interdialytic weight-gain (IDWG)
time frame: Over 12 months
description: Clinical measure obtained in routine clinical care
arm group label: Self-affirmation
arm group type: Experimental
description: In the self-affirmation arm, the patients completed a 10 item questionnaire about their past acts of kindness (self-affirmation) prior to reading the health risk information.
arm group label: Control
arm group type: No Intervention
description: Control patients completed 10 matched control questions with no self-affirming properties, prior to reading the health risk information.
intervention type: Other
intervention name: Health risk information
arm group label: Self-affirmation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Hertfordshire
investigator full name: Vari Wileman
investigator title: Researcher
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic