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A trial to study the effectiveness of Multi Component Behavioural Intervention programme on medication compliance and quality of life among elderly with chronic illness

A community based Randomized Controlled Trial (RCT) to determine the efficiency of Multi-component Behavioral Intervention Programme (MBIP) on medication compliance and quality of life among elderly with chronic illness residing in selected rural areas of Udupi district, Karnataka. - RCT

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/015962
Enrollment
480
Registered
2018-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I152- Hypertension secondary to endocrine disorders

Interventions

Intervention1: Multi component Behavioural Intervetion Programme: Elderly with chronic illness in the selected study setting with medication non-compliance (based on the HBMAS score) will receive the

Sponsors

Jeyalakshmi K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The rural area in villages which are covered by ASHA workers has more than 13 elderly with co-morbid conditions of hypertension and diabetes mellitus as on the survey data report. Elderly in the age group of above 60 years in both gender who resides in selected rural areas of Udupi Taluk. Elderly who is on prescribed medications for selected chronic illness. Elderly and family care giver who can speak and understand English or Kannada. Elderly with chronic illness or their care provider possess the mobile phone. Elderly with chronic illness those who are willing to participate in this study. Elderly with chronic illness and of either gender aged above 60 years receiving long term medications for more than 3 months.

Exclusion criteria

Exclusion criteria: Elderly those who could not follow the instructions of the investigator. Elderly those who are not diagnosed to have any chronic illness and not having medications. Elderly with chronic illness those who are newly diagnosed and taking medication less than 3 months for their conditions. Elderly with chronic illness those who had a previous experience of being part of any other project related to drug compliance. Elderly with any other major diagnosed co-morbid illness such as renal failure and other kidney disease, and other illness such as cancer in any situ, BPH, TB, HIV/AIDS.

Design outcomes

Primary

MeasureTime frame
Outcome measures for Phase I: Medication non-compliance of elderly with co-morbid chronic illnesses of hypertension and diabetes mellitus. Outcome measures for Phase II: Primary Outcome Measures: Improvement in medication compliance (Hill Bone Medication Adhrernce scores) scores after 3, 6 and 12 months after applying MBIP. Timepoint: Baseline, 3, 6, 12 Months

Secondary

MeasureTime frame
Improvement on bio-physiological values (Blood sugar, HbA1, BP, Lipid Profile). Increase in self-efficacy scores which will be measured by using MASES-R scale Increase in quality of life scores which will be measured by using WHO-QOL BREF Scale Client satisfaction and acceptability of the Multi-component Behavioral Intervention Programme (MBIP) by using rating scale. Timepoint: Baseline, 3, 6, 12 Months

Countries

India

Contacts

Public ContactDr Mahadev Rao

Manipal College of Nursing

elsa.sana@manipal.edu8310769938

Outcome results

None listed

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