The effects of etidronate on brain calcifications in Fahr's disease or syndrome: rationale and design of the randomised, placebo-controlled, double-blind CALCIFADE trial.

BACKGROUND: Fahr's disease and syndrome are rare disorders leading to calcification of the small arteries in the basal ganglia of the brain, resulting in a wide range of symptoms comprising cognitive decline, movement disorders and neuropsychiatric symptoms. No disease-modifying therapies are available. Studies have shown the potential of treatment of ectopic vascular calcifications with bisphosphonates. This paper describes the rationale and design of the CALCIFADE trial which evaluates the effects of etidronate in patients with Fahr's disease or syndrome. METHODS: The CALCIFADE trial is a randomised, placebo-controlled, double-blind trial which evaluates the effects of etidronate 20 mg/kg during 12 months follow-up in patients aged ≥ 18 years with Fahr's disease or syndrome. Etidronate and placebo will be administered in capsules daily for two weeks on followed by ten weeks off. The study will be conducted at the outpatient clinic of the University Medical Center Utrecht, the Netherlands. The primary endpoint is the change in cognitive functioning after 12 months of treatment. Secondary endpoints are the change in mobility, neuropsychiatric symptoms, volume of brain calcifications, dependence in activities of daily living, and quality of life. RESULTS: Patient recruitment started in April 2023. Results are expected in 2026 and will be disseminated through peer-reviewed journals as well as presentations at national and international conferences. CONCLUSIONS: Fahr's disease and syndrome are slowly progressive disorders with a negative impact on a variety of health outcomes. Etidronate might be a new promising treatment for patients with Fahr's disease or syndrome. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05662111. Registered 22 December 2022, https://clinicaltrials.gov/ct2/show/NCT01585402 .

Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial.

BACKGROUND: Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. OBJECTIVE: This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. METHODS: A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. RESULTS: The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. CONCLUSIONS: The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. TRIAL REGISTRATION: Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y).

A validation study of the Caregiver Mastery Scale for partners of patients with acquired brain injury.

OBJECTIVE: To validate the Caregiver Mastery Scale for partners of patients with acquired brain injury. DESIGN: The score distributions, internal consistency and convergent validity of the Caregiver Mastery Scale were determined. SUBJECTS: A total of 92 partners (53% male, age 62 years) of patients with acquired brain injury (91% stroke) discharged from inpatient rehabilitation (time since injury 32 months). MAIN MEASURES: Outcome measure: Caregiver Mastery Scale. Reference measures: Caregiver Strain Index, Hospital Anxiety and Depression Scale and CarerQoL. RESULTS: The Caregiver Mastery Scale has a normal distribution, with no floor or ceiling effects. Its internal consistency is acceptable (Cronbach's alpha: 0.75). The convergent validity analyses confirmed our hypothesis that higher scores on the Caregiver Mastery Scale correlate with less burden, lower levels of anxiety and depression and greater well-being. Furthermore, partners scoring high on the Caregiver Mastery Scale mostly scored below the clinical cut-off scores on the Caregiver Strain Index and the anxiety and depression subscales of the Hospital Anxiety and Depression Scale, whereas partners scoring low on the Caregiver Mastery Scale were more likely to score above the cut-off points. CONCLUSION: The Caregiver Mastery Scale is a valid instrument to assess the caregiver mastery of partners of patients with acquired brain injury.

Process evaluation of the Restore4stroke Self-Management intervention 'Plan Ahead!': a stroke-specific self-management intervention.

OBJECTIVE: To investigate whether the self-management intervention was implemented as intended. Additionally, we studied involvement in and satisfaction with the intervention among patients, their partners and therapists. DESIGN: Mixed method, prospective study. SETTING: Outpatient facilities of hospitals/rehabilitation centres. PARTICIPANTS: Stroke patients, their partners and therapists from the experimental arm of the Restore4Stroke Self-Management study. INTERVENTION: 'Plan Ahead!' is a 10-week self-management intervention for stroke patients and partners, consisting of seven two-hour group sessions. Proactive action planning, education and peer support are main elements of this intervention. MAIN MEASURES: Session logs, questionnaires for therapists, patients and their partners, and focus groups. DATA ANALYSIS: Qualitative data were analysed with thematic analysis supplemented by quasi-statistics. Quantitative data were reported as descriptive statistics. RESULTS: The study sample consisted of 53 patients and 26 partners taking part in the intervention, and all therapists delivering the intervention (N = 19). At least three-quarters of the intervention sessions were attended by 33 patients and 24 partners. On a scale from 1 to 10, patients, partners and therapists rated the intervention with mean scores of 7.5 (SD1.6), 7.8 (SD.7) and 7.4 (SD.7), respectively. Peer support was the most frequently appreciated element for participants and therapists. The proactive action planning tool was adequately applied in 76 of the 96 sessions. CONCLUSION: Although the target audience was reached and both participants and therapists were satisfied with the intervention, the proactive action planning tool that distinguishes the current intervention from existing stroke-specific self-management interventions was only partly implemented according to protocol.

The Restore4Stroke self-management intervention 'Plan ahead!': rationale and description of the treatment protocol based on proactive action planning.

OBJECTIVE: To describe the rationale behind and description of a group-based self-management intervention developed for stroke patients and their partners. RATIONALE: Based on the assumption that proactive coping strategies are beneficial for the re-uptake of daily life by stroke patients and partners, we developed a new stroke-specific, group-based self-management intervention based on proactive action planning. A first concept of the treatment protocol was developed based on the proactive coping theory, the Health Action Process Approach model, existing interventions and expert consultations. Further adjustments were based on two pilot studies, including addition of solution-based therapeutic techniques. DESCRIPTION OF THE INTERVENTION: 'Plan ahead!' is a 10-week group-based self-management intervention, consisting of six 2-hour sessions in the first six weeks and a 2-hour booster session in the 10th week. It is offered in an outpatient setting by two rehabilitation professionals with experience in group counselling and working with stroke patients. It is provided to groups of four stroke patients living at home (stroke ≥2 months ago) and their partners. The main features are (1) proactive action planning as the main constituent, (2) stroke-specific elements and (3) considering partners as full participants. DISCUSSION: This stroke-specific intervention is expected to increase the use of proactive action planning and thus improve the participation of stroke patients and their partners. It is innovative in its aim to change behaviour patterns of participants directly, teaching participants a general action planning strategy and considering partners as full participants with their own goals and opportunities.