Improving quality of life for south Tyrolean palliative patients in home care

Improving quality of life for south Tyrolean palliative patients in home care: a randomized controlled trial of home-based palliative care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10224372

Enrollment

106

Registered

2014-09-23

Start date

2014-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with terminal illness in palliative therapy treated at home Not Applicable

Interventions

Randomization method: block random assignment. 19 health districts (home care services) will be randomly assigned to either the intervention or control group. The randomization will be generated by Mi

(2) imparting of conversation techniques and strategies of clearly structured courses of conversation

(3) reflection about forms of the professional relationship level between health professionals and patients as well as relatives

(4) roles of care

(5) knowing, training and adjusting relevant communication techniques and strategies. The supervision meetings will take place twice in the period of one to two months (first meeting: one month after

second meeting: two to three and a half months after baseline). Participants (health professionals) will be asked about their sat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with advanced illness in palliative therapy, in home care (assessment by general practitioner in cooperation with mobile nursing service) 2. Age 18 years or above 3. Able to understand and sign informed consent 4. Able to fill out the questionnaires 5. Cared by family caregiver, nurse and general practitioner at home 6. Primary caregivers of the patient treated at home: family caregiver, nurse, general practitioner

Exclusion criteria

Exclusion criteria: 1. Karnofsky-Index less than or equal to 20; ECOG 4 (assessment by general practitioner) 2. Patients with strong cognitive impairment (no Alzheimer or dementia patients) 3. Life expectancy less than 2 months

Design outcomes

Primary

Measure	Time frame
Health-related quality of life (HRQOL) of patients. Measurements are taken three times: 1. Baseline, 2. Two months after baseline (during intervention, between intervention 1 and intervention 2) 3. Six months after baseline (after intervention) HRQOL of Patients measured by: FACT-G (Functional Assessment of Cancer Therapy - general; Version 4): This patient self-reported questionnaire is the core instrument of the Functional Assessment of Chronical Illness (FACIT) for patients with any form of cancer. It consists of 27 items which can be classified to four QOL domains: Physical Well-Being (7 items; range 0 - 28), Social/Family Well-Being (7 items; range 0 - 28), Emotional Well-Being (6 items; range 0 - 24), and Functional Well-Being (7 items; range 0 - 28). Patients rate items using a five-point Likert scale (0 ? 4). For each of these domains a summary score can be calculated, where high scores indicate a high level of well-being. A total score can be obtained by summarising all individual subscale scores (Webster, Cella & Yost, 2003).	—

Measure

Time frame

Health-related quality of life (HRQOL) of patients. Measurements are taken three times: 1. Baseline, 2. Two months after baseline (during intervention, between intervention 1 and intervention 2) 3. Six months after baseline (after intervention) HRQOL of Patients measured by: FACT-G (Functional Assessment of Cancer Therapy - general; Version 4): This patient self-reported questionnaire is the core instrument of the Functional Assessment of Chronical Illness (FACIT) for patients with any form of cancer. It consists of 27 items which can be classified to four QOL domains: Physical Well-Being (7 items; range 0 - 28), Social/Family Well-Being (7 items; range 0 - 28), Emotional Well-Being (6 items; range 0 - 24), and Functional Well-Being (7 items; range 0 - 28). Patients rate items using a five-point Likert scale (0 ? 4). For each of these domains a summary score can be calculated, where high scores indicate a high level of well-being. A total score can be obtained by summarising all individual subscale scores (Webster, Cella & Yost, 2003).

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Secondary

Measure	Time frame
1. Quality of care: POS (Palliative care Outcome Scale) The questionnaire is a Patient-Reported Outcome Scale which measures outcomes and assesses quality of care in palliative care patients. The questionnaire consists of two almost identical scales ? one for patients and one for health professionals and caregiver - each of them consists of 11 items, which can be rated on a Likert scale from 0 to 4. Physical, psychosocial, spiritual, organizational and practical domains of palliative care can be measured with it. With the last item, an open question, patients and health professionals or caregivers are asked to indicate the ?main problem of the care process? (Hearn & Higginson, 1999). 2. Patient-related secondary outcomes: 2.1. Symptom control measured by the scales of the FACT-G and POS 2.2. Anxiety and depression measured by the HADS (Hospital Anxiety and Depression Scale). This self-assessment questionnaire consists of 14 items, rated on a Likert scale from 0 ? 3. Two scores can be calculated: HADS-A (7 items) and HADS-D (7 items) which range from 0 to 21 (Snaith, 2003). 2.3. Satisfaction with care (incl. communication and support) measured by a self-constructed Visual Analogue Scale (VAS); scale items can be rated along a continuous line between the two end-points 0 = unsatisfied and 100 = satisfied. 2.4. Sense of Coherence measured by the short-form of the Sense of Coherence Scale (SOC ? 13). This instrument consists of 13 items, which can be rated on a 7-point Likert scale. The theory of the Sense of Coherence is based on Antonovsky?s salutogenic approach. The Sense of Coherence as a personal resource is composed of the following three components: Comprehensibility, Manageability and Meaningfulness. The 13 items can be assigned to one of the three components (Antonovsky, 1987). 3. Family caregiver-related secondary outcomes: 3.1. HRQOL of family caregivers measured by the SF-12 (Short-Form Health Survey - 12 items). The Short-Form Health Survey is a self-	—

Measure

Time frame

1. Quality of care: POS (Palliative care Outcome Scale) The questionnaire is a Patient-Reported Outcome Scale which measures outcomes and assesses quality of care in palliative care patients. The questionnaire consists of two almost identical scales ? one for patients and one for health professionals and caregiver - each of them consists of 11 items, which can be rated on a Likert scale from 0 to 4. Physical, psychosocial, spiritual, organizational and practical domains of palliative care can be measured with it. With the last item, an open question, patients and health professionals or caregivers are asked to indicate the ?main problem of the care process? (Hearn & Higginson, 1999). 2. Patient-related secondary outcomes: 2.1. Symptom control measured by the scales of the FACT-G and POS 2.2. Anxiety and depression measured by the HADS (Hospital Anxiety and Depression Scale). This self-assessment questionnaire consists of 14 items, rated on a Likert scale from 0 ? 3. Two scores can be calculated: HADS-A (7 items) and HADS-D (7 items) which range from 0 to 21 (Snaith, 2003). 2.3. Satisfaction with care (incl. communication and support) measured by a self-constructed Visual Analogue Scale (VAS); scale items can be rated along a continuous line between the two end-points 0 = unsatisfied and 100 = satisfied. 2.4. Sense of Coherence measured by the short-form of the Sense of Coherence Scale (SOC ? 13). This instrument consists of 13 items, which can be rated on a 7-point Likert scale. The theory of the Sense of Coherence is based on Antonovsky?s salutogenic approach. The Sense of Coherence as a personal resource is composed of the following three components: Comprehensibility, Manageability and Meaningfulness. The 13 items can be assigned to one of the three components (Antonovsky, 1987). 3. Family caregiver-related secondary outcomes: 3.1. HRQOL of family caregivers measured by the SF-12 (Short-Form Health Survey - 12 items). The Short-Form Health Survey is a self-

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026