Piloting an Intervention for Improving Treatment Adherence

NCT02250235 | Completed DMC

• 1 other identifier: 111154_14238
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Self-reported appraisal of health risk information

  Perceptions of the health risk, intention and self efficacy towards future treatment adherence

  Collected immediately after presentation of health risk information (baseline)

Secondary Outcomes (1)

• Interdialytic weight-gain (IDWG)

  Over 12 months

Study Arms (2)

Self-affirmation

EXPERIMENTAL

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.

Other: Health risk information

Control

NO INTERVENTION

Control patients completed 10 matched control questions with no self-affirming properties, prior to reading the health risk information.

Interventions

Health risk information OTHER

Self-affirmation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (over 18 years) haemodialysis patients
• Fluency in spoken and written English
• ≥ 3 months from initiation of dialysis
• Three month Interdialytic Weight Gain (IDWG) \> 2.0 kg\*
• Residual renal urea clearance (KRU) \<1ml/min or reported urine output\<200mls per day.\*

You may not qualify if:

• Hospitalised at the time of study or during the two months prior for reasons other than dialysis
• Being treated for other condition assessed as compromising treatment or participation in study (e.g. mental health)
• In preparation for live donor transplant

Sponsors & Collaborators

• University of Hertfordshire: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09